Purpose of This PDQ Summary
Overview
General Information
History
Laboratory/Animal/Preclinical Studies
Human/Clinical Studies
Adverse Effects
Overall Level of Evidence for the Gonzalez Regimen
Changes to This Summary (04/24/2008)
More Information

Purpose of This PDQ Summary

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of the Gonzalez regimen as a treatment for cancer. The summary is reviewed regularly and updated as necessary by the PDQ Cancer Complementary and Alternative Medicine Editorial Board ¹.

Information about the following is included in this summary:

• A brief history of Gonzalez regimen research.
• The results of clinical studies of the Gonzalez regimen.
• Possible side effects of the Gonzalez regimen.

This summary is intended as a resource to inform and assist clinicians and other health professionals who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Some of the reference citations in the summary are accompanied by a level of evidence designation. These designations are intended to help the readers assess the strength of the evidence supporting the use of specific interventions or treatment strategies. The PDQ Cancer Complementary and Alternative Medicine Editorial Board uses a formal evidence ranking system ² in developing its level of evidence designations. These designations should not be used as a basis for reimbursement determinations.

This summary is also available in a patient version ³, which is written in less technical language.

Overview

This complementary and alternative medicine (CAM) information summary provides an overview of the Gonzalez regimen as a treatment for cancer. The summary includes a brief history of the science and philosophies of care that have influenced development of the regimen, the results of research and clinical studies, and side effects that have been associated with this treatment approach.

This summary contains the following key information:

• The Gonzalez regimen is a complex cancer treatment that is tailored by the practitioner for each specific patient.
• Existing clinical data concerning the effectiveness of the Gonzalez regimen as a treatment for cancer are limited and inconclusive.
• Pancreatic enzymes taken orally are the primary agents within the regimen thought to have direct antitumor effects. The enzymes are derived from porcine (pig) sources.
• The regimen also includes specific diets, vitamin and mineral supplements, extracts of animal organs, and coffee enemas.
• The Gonzalez regimen is currently available only to the patients of its developer and to those participating in ongoing clinical trials evaluating its effectiveness.
• A variety of diet regimens similar to those in the Gonzalez regimen are associated with cancer prevention, but none have been shown to be effective as cancer treatments.
• Compliance with the Gonzalez regimen may be extremely difficult for patients because of the large number of pills taken per day (150) and the strict dietary protocols.

Many of the medical and scientific terms used in this summary are hypertext linked (at first use in each section) to the NCI Dictionary ⁴, which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window. All linked terms and their corresponding definitions will appear in a glossary in the printable version of the summary.

Reference citations in some PDQ CAM information summaries may include links to external Web sites that are operated by individuals or organizations for the purpose of marketing or advocating the use of specific treatments or products. These reference citations are included for informational purposes only. Their inclusion should not be viewed as an endorsement of the content of the Web sites, or of any treatment or product, by the PDQ Cancer CAM Editorial Board or NCI.

General Information

The Gonzalez regimen combines prescribed diets, nutritional supplements, coffee enemas, and pancreatic enzymes in a cancer management program. The regimen is intended to detoxify the body, correct nervous system imbalances that might lead to impaired general health, and support natural immune processes. The pancreatic enzymes are thought to be the specific anticancer component of the Gonzalez program.[1-4]

Two major concepts underlie use of the Gonzalez regimen in cancer treatment. The first concept is that the pancreas, like the liver, is an organ that performs a detoxification function and that pancreatic enzymes help the body eliminate toxins and help normal cells repair damaged cells.[2] The second concept is that cancer and most other human illness are related to physiological imbalances created by environmental toxins either consumed in food or contacted in the environment.[2,4]

Proponents of the Gonzalez regimen believe that toxins from sources such as processed foods and environmental pollution are responsible for human cancers. These toxins are thought to accumulate in tissues and over time create imbalances in the autonomic nervous system, diminish the normal immune response, and give rise to cellular damage that can lead to cancer.[2,4] If these toxins could be neutralized and eliminated from the body, proponents believe, both early and established cancers would be halted, and general health would be restored.[2,4]

According to the developer of the Gonzalez regimen, the diets used in this regimen are chosen for each patient according to individual metabolic profiles established at the time of initial evaluation through various tests, including hair analysis. There are ten basic diets and 90 variations.[2] The diets emphasize organic foods. Each diet carries a particular focus and can range from strictly vegetarian diets to diets high in meat and fat. Variations in the diets correlate with the theory that imbalances in the autonomic nervous system are exacerbated by a diet that is inappropriate for the patient’s metabolic type.[2,4]

Nutritional supplements employed in the Gonzalez regimen include vitamins, minerals, trace elements, amino acids, and extracts of animal organs (e.g., thymus and liver extracts from sheep or cows). As with the dietary protocols, the nutritional supplements are intended to correct autonomic nervous system imbalances.[2-4]

The major feature of the Gonzalez regimen is freeze-dried porcine pancreatic enzyme (PPE) administered in capsule form as part of the nutritional supplementation aspect of the program. Obtained from pigs, PPE is considered to be the primary cancer-fighting component in the regimen and to contribute to the overall detoxification process.[2]

Proponents of the regimen believe that the pancreatic enzymes are delivered to the bloodstream and help the body eliminate and destroy abnormal cells, waste material, and abnormal proteins that are toxic to the body. As the body detoxifies, the cancerous tumors tend to shrink.[2]

Coffee enemas are also included as part of the detoxification process. The enemas are administered twice daily.[4] The use of coffee enemas is based on a belief that coffee introduced into the lower intestinal tract will improve liver function and stimulate emptying of the gallbladder, thereby enhancing the elimination of toxins and waste products from the body.[2-4]

The Gonzalez regimen is available only to private patients of its New York-based practitioner [3] and to those participating in a clinical trial (CPMA-IRB-8544 ⁵) sponsored by the National Center for Complementary and Alternative Medicine and the National Cancer Institute.

Pancreatic enzymes are sold in the United States as either prescription drugs indicated for pancreatic insufficiency [5] or over-the-counter (OTC) dietary supplements. As of 2004, those sold as prescription drugs must have a New Drug Approval from the US Food and Drug Administration (FDA) to be marketed legally in the United States. Pancreatic enzymes sold as OTC dietary supplements are regulated as foods, not drugs, and the FDA has no jurisdiction over the regulation of foods. Dietary supplements in the United States are therefore sold without any regulation by the FDA, as long as they do not claim to treat or prevent a specific disease or condition. According to the developer of the Gonzalez regimen, OTC preparations or other commercially available pancreatic enzymes are not effective against cancer.[4]

The PPE preparation used in the Gonzalez regimen is manufactured in New Zealand for use in the program.[3]

For the FDA, PPE falls under the category of a new prescription drug that is under investigation. To conduct clinical drug research in the United States, researchers must file an Investigational New Drug (IND) application with the FDA. To date, only one group of investigators is known to have IND approval to study this pancreatic enzyme preparation as a treatment for cancer. The IND process is confidential, and the existence of an IND can be disclosed only by the applicant(s).

References

1. Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 33 (2): 117-24, 1999.  [PUBMED Abstract]
   
   
2. Gonzalez N: Dr. Nicholas Gonzalez on nutritional cancer therapy: a Moneychanger interview. The Moneychanger July 1995. Also available online ⁶. Last accessed February 4, 2008. 
   
   
3. Gonzalez N, Kushi L: The dietary treatment of cancer (part II). In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies - A Conference for Health professionals, June 12-14, 1998. Breakout Session 404. Available online ⁷. Last accessed May 2, 2006. 
   
   
4. Gonzalez NJ: Pancreatic cancer, proteolytic enzyme therapy and detoxification [excerpts]. Clinical Pearls News November 1999. Also available online ⁸. Last accessed February 4, 2008. 
   
   
5. Physician's Desk Reference 2005. 59th ed. Montvale, NJ: Thomson PDR, 2005. 
   
   

History

The Gonzalez regimen was developed by Dr. Nicholas Gonzalez, who became interested in the use of pancreatic enzymes and dietary protocols as a possible treatment for cancer as a second-year medical student when he learned of a cancer treatment approach developed by a Texas dentist, William Donald Kelley, D.D.S. Dr. Kelley’s approach espoused, among other things, the use of pancreatic enzymes administered orally as anticancer agents.[1] Reviewed in [2-6] The use of enzymes as a treatment for cancer was originally proposed nearly a century ago [7] and then resurfaced in the work of Dr. Max Gerson in the 1940s.[8] The Gonzalez regimen developed from these earlier theories and approaches.

A key concept underlying the original use of pancreatic enzymes for cancer treatment is the trophoblastic theory of cancer.[9] When a human egg is fertilized by sperm, the early cell divisions produce a small ball of cells, which give rise to the blastocyst (preimplantation embryo). The blastocyst possesses a surrounding layer of cells known as the trophoectoderm, which is made of individual cells called trophoblasts. Responsible for protecting the developing blastocyst and for mediating its attachment to the wall of the uterus, trophoblasts create the placenta. During the process of attaching the blastocyst to the uterine wall, trophoblasts express invasive qualities similar to those found in cancer cells. Trophoblasts, however, cease their invasive activity once the placenta is in place and functioning and then differentiate into other cell types.[9]

When Scottish embryologist Dr. John Beard [7] first observed the invasive activity of trophoblasts in 1902, he speculated on the similarities between these cells and cancer cells. In addition, he observed that trophoblast invasiveness begins to decline at about the same time that the pancreas in the developing fetus begins to function. He also theorized that maternal pancreatic enzymes might play a role in containing trophoblastic invasiveness in the uterus. These considerations led to his proposal that cancer cells, like trophoblasts, arise from primordial germ cells. Dr. Beard also thought that some of these primordial cells—carrying latent capacities for invading tissues—could escape and spread throughout the body of the developing fetus. He thought it was possible that pancreatic enzymes modulated the degree of trophoblastic invasiveness in the uterus, he suggested that these same enzymes play a role in either limiting or eliminating cancerous cells elsewhere in the body.[7] Reviewed in [9] Dr. Beard worked before the advent of molecular biology and human genetics. Although unable to experimentally establish that pancreatic enzymes had anticancer effects, he published papers and a book about his theory between 1902 and 1911. Other scientists of the time raised significant objections to the trophoblastic theory of cancer, and it was never broadly accepted. Reviewed in [10]

As Dr. Beard had before him, Dr. Kelley also asserted that trophoblasts and cancer cells have a common origin in primordial germ cells. Dr. Kelley maintained, furthermore, that cancer was initiated when primordial germ cells migrated to a point in the body already weakened by toxic exposure and nervous system imbalance. At these presumably compromised sites, the germ cells met no opposition from the immune system and initiated an aggressive invasion of normal tissue, creating malignancy. Dr. Kelley’s treatment approach was based on the belief that primordial germ cells are the single cause of all cancers, no matter where they occur, and that pancreatic enzymes are able to suppress or destroy cancers.[1,6]

Dr. Gonzalez incorporated many of Dr. Beard’s and Dr. Kelley’s key points into his own treatment regimen. In addition, the Gonzalez regimen includes the rigorous dietary protocols, nutritional supplements, and coffee enemas that can be found in the earlier work of Dr. Max Gerson.[8] The Gonzalez regimen now includes use of pancreatic enzymes, along with nutritional supplements, coffee enemas, and prescriptive diets based on a theory of autonomic dominance.[2-5]

An example of the Gonzalez regimen for a patient with pancreatic adenocarcinoma would be the following:

1. A diet that emphasizes fresh raw fruits, raw and lightly steamed vegetables, and freshly made vegetable juice daily. The diet protocol relies on plant-based sources such as cereals, nuts, and seeds and whole-grain products such as whole-grain bread and brown rice. The patient may eat one or two eggs daily, whole-milk yogurt daily, and fish two or three times a week, but no red meat or poultry.
2. Nutritional supplements that include vitamins, minerals, and trace elements. Also prescribed are certain freeze-dried organ concentrates such as thymus and liver, derived from beef or lamb.
3. Ingestion of 25 g to 40 g of porcine lyophilized pancreas product daily, in capsule form, taken away from meals and spread evenly throughout the day.[2]

The total number of capsules taken per day by each cancer patient on the Gonzalez regimen typically ranges from 130 to 160, taken with and away from meals.[2] In addition, the Gonzalez regimen uses coffee enemas on the premise that coffee absorbed through the intestinal wall will improve liver and gallbladder function and help increase the removal of toxic waste from tumor breakdown.[2,4,5] At this time there is no scientific evidence that coffee enemas have any specific effects on increased liver function, effects on tumor breakdown detoxification, or a role in the treatment of any cancer.

Doubts exist about the effectiveness of oral administration of pancreatic enzymes because pancreatic enzymes were not thought to be transported intact from the gut to the bloodstream. Evidence now suggests that intact digestive enzymes can be absorbed and resecreted by the pancreas, in a manner similar to the liver recycling of bile salts and hormones.[11-13]

References

1. Kelley WD: One Answer to Cancer. Mount Pearl, Canada: Cancer Coalition for Alternative Therapies, Inc. 1999. Also available online. ⁹ Last accessed February 4, 2008. 
   
   
2. Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 33 (2): 117-24, 1999.  [PUBMED Abstract]
   
   
3. Gonzalez N: Dr. Nicholas Gonzalez on nutritional cancer therapy: a Moneychanger interview. The Moneychanger July 1995. Also available online ⁶. Last accessed February 4, 2008. 
   
   
4. Gonzalez N, Kushi L: The dietary treatment of cancer (part II). In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies - A Conference for Health professionals, June 12-14, 1998. Breakout Session 404. Available online ⁷. Last accessed May 2, 2006. 
   
   
5. Gonzalez NJ: Pancreatic cancer, proteolytic enzyme therapy and detoxification [excerpts]. Clinical Pearls News November 1999. Also available online ⁸. Last accessed February 4, 2008. 
   
   
6. Kelley WD, Rohe F: Cancer: Curing the Incurable without Surgery, Chemotherapy, or Radiation. Bonita, Calif: New World Promotions, 2005. 
   
   
7. Beard J: The Enzyme Treatment of Cancer and its Scientific Basis. London: Chatto & Windus, 1911. 
   
   
8. Gerson M: The cure of advanced cancer by diet therapy: a summary of 30 years of clinical experimentation. Physiol Chem Phys 10 (5): 449-64, 1978.  [PUBMED Abstract]
   
   
9. Krebs ET Jr, Krebs ET Sr, Beard HH: The unitarian or trophoblastic thesis of cancer. Med Rec 163 (7): 149-74, 1950. 
   
   
10. Cohen LA, Aliaga C, Pittman B, et al.: Oral enzyme therapy and experimental rat mammary tumor metastasis. Life Sci 65 (24): 2603-14, 1999.  [PUBMED Abstract]
    
    
11. Leibow C, Rothman SS: Enteropancreatic circulation of digestive enzymes. Science 189 (4201): 472-4, 1975.  [PUBMED Abstract]
    
    
12. Rothman S, Liebow C, Isenman L: Conservation of digestive enzymes. Physiol Rev 82 (1): 1-18, 2002.  [PUBMED Abstract]
    
    
13. Isenman L, Liebow C, Rothman S: Transport of proteins across membranes--a paradigm in transition. Biochim Biophys Acta 1241 (3): 341-70, 1995.  [PUBMED Abstract]
    
    

Laboratory/Animal/Preclinical Studies

Directly relevant laboratory or animal data concerning the anticancer potential of the Gonzalez regimen are limited. Published animal studies focus on the role of pancreatic enzymes in cancer treatment rather than the regimen as a whole.

An animal study published in 1999 measured the ability of orally administered porcine pancreas preparation (PPP) to slow or halt the growth of cancer and to inhibit metastasis. Sixty Fischer F344 female rats were divided into five groups of 12 each. All groups were fed the same basic diet. After 5 days, R13762 transplantable rat mammary tumor was implanted into a mammary fat pad on each rat. The animals were maintained on their assigned diets for another 40 days. After the tumors had taken hold, two groups were given a high dose of PPP (20% by weight) and two groups were given a lower dose (2% by weight). The fifth group was used as a control and received no enzymes. In addition, one group from each of the PPP-dosed rat groups was also given a magnesium citrate supplement because magnesium is often given with PPP in clinical practice.[1]

Results showed that PPP had no effect on tumor growth, and PPP alone did not show any significant effect on the amount of metastases. However, when the rate of metastases in the rats dosed at the 20% rate was compared with those dosed at 2%, it was noted that there was an increase in metastases in the rats given a higher dose of PPP. The lowest rate of metastases was seen in the rats given the 2% dose plus magnesium citrate.[1]

In another study, the effects of porcine pancreatic enzyme (PPE) extracts on survival and tumor growth were examined in 5- to 6-week-old male beige X-linked immunodeficient mice. In the survival study, two groups of mice received pancreatic cancer cells AsPc1 injected into their pancreas. The treatment group (14 mice) received PPE in water at a dose of 400 mg/kg of body weight, which corresponds to the dose used in patients receiving the Gonzalez regimen. The control group (13 mice) was given only water. After death, the pancreas was removed and measured for volume and weight. The median survival rates for the treatment group and the control group were 43.5 days and 35 days, respectively. At day 35, the survival rates were 79% in the treatment group and 38% in the control group. In addition, the control mice showed reduced activity as compared with the treatment group, which showed normal activity and no signs of disease. In general, the size of tumors and the rate of invasion in the liver and peritoneum correlated with length of survival time.[2]

In the tumor growth segment of this study, a second group of 30 mice was taken through the same procedures. Tumor size and weight were measured in two mice from each group on day 52, and again in two mice from the control group and five mice from the treatment group on day 60. Ascites were much more apparent in the control group than in the treatment group. Physical activity among the treated mice was much greater than in the control group. Results showed that the treatment group had significantly smaller tumors than the control group in both weight and volume. The mean tumor weight was 1.2 g in the control group and 0.75 g in the treatment group. The tumor volume was 0.42 cm³ in the treatment group and 0.91 cm³ in the control group. All mice in the control group showed steatorrhea, hyperglycosuria, hyperbilirubinuria, and ketonuria in the early stages of tumor growth, whereas in the treated group only a few mice showed these abnormalities in the final stages. There were no differences in the tumors of the treatment and control groups in the expression of growth factors, epidermal growth factor receptor, or apoptotic rate.[2]

References

1. Cohen LA, Aliaga C, Pittman B, et al.: Oral enzyme therapy and experimental rat mammary tumor metastasis. Life Sci 65 (24): 2603-14, 1999.  [PUBMED Abstract]
   
   
2. Saruc M, Standop S, Standop J, et al.: Pancreatic enzyme extract improves survival in murine pancreatic cancer. Pancreas 28 (4): 401-12, 2004.  [PUBMED Abstract]
   
   

Human/Clinical Studies

The anticancer efficacy of the Gonzalez regimen has been investigated in two human studies (CPMC-IRB-8544 ⁵), both involving patients with pancreatic cancer.

The first study, a prospective nonconsecutive case series conducted by the developer and an associate, included 11 patients diagnosed with adenocarcinoma of the pancreas (stage II or stage IV). None of the patients had received chemotherapy or radiation therapy, and none had undergone surgical resection with curative intent. All the patients had pancreatic tumors that were either unresected or partially resected. Survival from the time of diagnosis was the only study endpoint, and all 11 patients (including one who left the study) were included in this survival analysis.

The investigators reported a median survival time of 17 months and a mean survival time of 25.2 months for these patients. Nine patients (82%) survived 1 year, five patients (45%) survived 2 years, and four patients (36%) survived 3 years. At the time the study was reported, two patients were alive: one who had survived 3 years, and one who had survived 4 years. The researchers concluded that the 1-year and 2-year survival percentages for this group of patients were superior to those observed for other U.S. patients diagnosed with adenocarcinoma of the pancreas (1-year survival, all stages = 25%; 2-year survival, all stages = 10%).[1]

The small number of patients in this study and the absence of a control group are limitations that raise doubts about the reliability of its findings. It is possible that important, unidentified differences between these patients and other patients diagnosed with stage II to stage IV pancreatic cancer contributed to the relatively long survival. The investigators report that 25 additional patients with pancreatic cancer were seen during the study period but were excluded from study participation. Eleven of these patients were excluded on the basis of comorbidities, previous treatment, or delay between diagnosis and beginning the program; 14 otherwise eligible patients were excluded on the grounds that they chose not to start the program, complied only briefly, or predicted noncompliance.[1]

The second study is a nonrandomized prospective case-controlled phase III clinical trial (CPMC-IRB-8544) sponsored by the National Center for Complementary and Alternative Medicine and the National Cancer Institute in which survival and quality of life are being compared between patients treated with the Gonzalez regimen and patients treated on other clinical trials with gemcitabine -based (i.e., other drugs may be included) chemotherapy. Up to 90 patients with inoperable stage II, III, or IV adenocarcinoma of the pancreas are planned for accrual. This study was originally planned for randomization but changed after few patients elected to participate in the randomized trial. The patients in both groups of the current trial must meet the same eligibility criteria. This study is still ongoing.

No data concerning the effectiveness of the Gonzalez regimen for the treatment of cancer patients with other types of cancer have been reported, despite claims that a variety of cancers can be treated. In addition, there is no safety or efficacy information on the regimen in children. No clinical trials of this regimen have been conducted in children, and this extremely difficult regimen may be prohibitive in young children.

References

1. Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 33 (2): 117-24, 1999.  [PUBMED Abstract]
   
   

Adverse Effects

The developer of the Gonzalez regimen has reported the following adverse effects associated with the regimen: intestinal gas; occasional bloating and indigestion, apparently related to ingestion of porcine pancreatic enzyme; and flu-like syndromes, allegedly associated with detoxification, including low-grade fever, nonspecific myalgia (muscle aches), and nonspecific skin rashes.[1,2] The cases found in the literature on coffee enema are not adequate to support an adverse effect from coffee enemas alone. There are rare reports of adverse events unrelated to the coffee enemas in patients receiving them. It should be remembered that clinically significant changes in blood chemistries can occur with excessive use of enemas of any kind.[3-6]

References

1. Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 33 (2): 117-24, 1999.  [PUBMED Abstract]
   
   
2. Gonzalez NJ: Pancreatic cancer, proteolytic enzyme therapy and detoxification [excerpts]. Clinical Pearls News November 1999. Also available online ⁸. Last accessed February 4, 2008. 
   
   
3. Green S: A critique of the rationale for cancer treatment with coffee enemas and diet. JAMA 268 (22): 3224-7, 1992.  [PUBMED Abstract]
   
   
4. Margolin KA, Green MR: Polymicrobial enteric septicemia from coffee enemas. West J Med 140 (3): 460, 1984.  [PUBMED Abstract]
   
   
5. Brown BT: Treating cancer with coffee enemas and diet. JAMA 269 (13): 1635-6, 1993.  [PUBMED Abstract]
   
   
6. Eisele JW, Reay DT: Deaths related to coffee enemas. JAMA 244 (14): 1608-9, 1980.  [PUBMED Abstract]
   
   

Overall Level of Evidence for the Gonzalez Regimen

Existing clinical data concerning the effectiveness of the Gonzalez regimen as a treatment for cancer are limited and inconclusive. To date, only one clinical study, a nonconsecutive case series involving 11 patients with pancreatic cancer, has been reported. Another clinical study involving patients with pancreatic cancer is currently under way, but no results have been reported. No data concerning the effectiveness of the Gonzalez regimen in patients with other types of cancer have been reported.

To assist readers in evaluating the results of human studies of complementary and alternative medicine (CAM) treatments for cancer, the strength of the evidence (i.e., the levels of evidence) associated with each type of treatment is provided whenever possible. To qualify for a level of evidence analysis, a study must:

• Be published in a peer-reviewed scientific journal.
• Report on a therapeutic outcome or outcomes, such as tumor response, improvement in survival, or measured improvement in quality of life.
• Describe clinical findings in sufficient detail that a meaningful evaluation can be made.

Separate levels of evidence scores are assigned to qualifying human studies on the basis of statistical strength of the study design and scientific strength of the treatment outcomes (i.e., endpoints) measured. The resulting two scores are then combined to produce an overall score. For an explanation of the scores and additional information about levels of evidence analysis of CAM treatments for cancer, refer to Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine ².

Changes to This Summary (04/24/2008)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

Editorial changes were made to this summary.

More Information

Additional Information about CAM Therapies

• The National Center for Complementary and Alternative Medicine ¹⁰ (NCCAM).
• The National Cancer Institute Office of Cancer Complementary and Alternative Medicine ¹¹ (OCCAM).
• CAM on PubMed ¹², a special subset of the PubMed scientific literature database created through a partnership between NCCAM and the National Library of Medicine.

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Important:

This information is intended mainly for use by doctors and other health care professionals. If you have questions about this topic, you can ask your doctor, or call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

Glossary Terms

Not normal. An abnormal lesion or growth may be cancerous, premalignant (likely to become cancer), or benign.

Cancer that begins in cells that line certain internal organs and that have gland-like (secretory) properties.

An unwanted side effect of treatment.

A quickly growing cancer.

One of several molecules that join together to form proteins. There are 20 common amino acids found in proteins.

A process in which anything complex is separated into simple or less complex parts.

Abnormal buildup of fluid in the abdomen that may cause swelling. In late-stage cancer, tumor cells may be found in the fluid in the abdomen. Ascites also occurs in patients with liver disease.

A fluid made by the liver and stored in the gallbladder. Bile is excreted into the small intestine, where it helps digest fat.

A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.

A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.

Treatment with drugs that kill cancer cells.

Having to do with the examination and treatment of patients.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical trial.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

The injection of coffee through the anus into the colon (large intestine). Coffee enemas are being tested in the treatment of pancreatic cancer.

Forms of treatment that are used in addition to (complementary) or instead of (alternative) standard treatments. These practices generally are not considered standard medical approaches. Standard treatments go through a long and careful research process to prove they are safe and effective, but less is known about most types of CAM. CAM may include dietary supplements, megadose vitamins, herbal preparations, special teas, acupuncture, massage therapy, magnet therapy, spiritual healing, and meditation. Also called CAM.

In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.

A health professional who specializes in caring for the teeth, gums, and other tissues in the mouth.

The process of identifying a disease, such as cancer, from its signs and symptoms.

The things a person eats and drinks.

The amount of medicine taken, or radiation given, at one time.

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

Effectiveness. In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect.

In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.

Early stage in the development of a plant or an animal. In vertebrate animals (have a backbone or spinal column), this stage lasts from shortly after fertilization until all major body parts appear. In particular, in humans, this stage lasts from about 2 weeks after fertilization until the end of the seventh or eighth week of pregnancy.

In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor.

A protein that speeds up chemical reactions in the body.

The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor. Also called EGFR, ErbB1, and HER1.

In medicine, a preparation of a substance obtained from plants, animals, or bacteria and used as a drug or in drugs.

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.

A method used to dry substances, such as food, to make them last longer. The substance is frozen and then dried in a vacuum.

The pear-shaped organ found below the liver. Bile is concentrated and stored in the gallbladder.

A drug that is used to treat certain types of breast cancer, pancreatic cancer, ovarian cancer, and lung cancer and is being studied in the treatment of other types of cancer. Gemcitabine is a type of antimetabolite. Also called gemcitabine hydrochloride and Gemzar.

Inherited; having to do with information that is passed from parents to offspring through genes in sperm and egg cells.

A reproductive cell of the body. Germ cells are egg cells in females and sperm cells in males.

An alternative therapy that is being studied as a treatment for pancreatic cancer. It includes a special diet, nutritional supplements, pancreatic enzymes, and coffee enemas.

A substance made by the body that functions to regulate cell division and cell survival. Some growth factors are also produced in the laboratory and used in biological therapy.

One of many chemicals made by glands in the body. Hormones circulate in the bloodstream and control the actions of certain cells or organs. Some hormones can also be made in the laboratory.

The activity of the immune system against foreign substances (antigens).

The complex group of organs and cells that defends the body against infections and other diseases.

A substance or object that is put in the body as a prosthesis, or for treatment or diagnosis.

Taking into the body by mouth.

Use of a syringe and needle to push fluids or drugs into the body; often called a "shot."

Describes a condition that cannot be treated by surgery.

Having to do with the intestines.

In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental.

Describes a condition that is present but not active or causing symptoms.

A ranking system used to describe the strength of the results measured in a clinical trial or research study. The design of the study (such as a case report for an individual patient or a randomized double-blinded controlled clinical trial) and the endpoints measured (such as survival or quality of life) affect the strength of the evidence.

A large organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile.

When referring to cancerous and precancerous growths, a term used to describe cells that look nearly normal under a microscope. These cells are less likely to grow and spread quickly than cells in high-grade cancerous or precancerous growths.

In medicine, a mineral used by the body to help maintain muscles, nerves, and bones. It is also used in energy metabolism and protein synthesis.

A cancerous tumor that can invade and destroy nearby tissue and spread to other parts of the body.

Having to do with the breast.

A statistics term. The average value in a set of measurements. The mean is the sum of a set of numbers divided by how many numbers are in the set.

The average time that patients in a clinical study remained alive. The time is measured beginning either at diagnosis or the start of treatment.

The time from either diagnosis or treatment at which half of the patients with a given disease are found to be, or expected to be, still alive. In a clinical trial, median survival time is one way to measure how effective a treatment is.

Having to do with metabolism (the total of all chemical changes that take place in a cell or an organism to produce energy and basic materials needed for important life processes).

The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a “metastatic tumor” or a “metastasis.” The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).

In medicine, a mineral is a nutrient that is needed in small amounts to keep the body healthy. Mineral nutrients include the elements calcium, magnesium, and iron.

Pain in a muscle or group of muscles.

The National Cancer Institute, part of the National Institutes of Health of the United States Department of Health and Human Services, is the Federal Government's principal agency for cancer research. The National Cancer Institute conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the National Cancer Institute Web site at http://www.cancer.gov. Also called NCI.

NCI, part of the National Institutes of Health of the United States Department of Health and Human Services, is the Federal Government's principal agency for cancer research. It conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the NCI Web site at http://www.cancer.gov. Also called National Cancer Institute.

A clinical study that includes some, but not all, of the eligible patients identified by the researchers during the study registration period. This type of study does not usually have a control group.

The taking in and use of food and other nourishing material by the body. Nutrition is a 3-part process. First, food or drink is consumed. Second, the body breaks down the food or drink into nutrients. Third, the nutrients travel through the bloodstream to different parts of the body where they are used as "fuel" and for many other purposes. To give the body proper nutrition, a person has to eat and drink enough of the foods that contain key nutrients.

Closely monitoring a patient's condition but withholding treatment until symptoms appear or change. Also called active surveillance, expectant management, and watchful waiting.

By or having to do with the mouth.

A part of the body that performs a specific function. For example, the heart is an organ.

A medicine that can be bought without a prescription (doctor's order). Examples include analgesics (pain relievers) such as aspirin and acetaminophen. Also called nonprescription and OTC.

A glandular organ located in the abdomen. It makes pancreatic juices, which contain enzymes that aid in digestion, and it produces several hormones, including insulin. The pancreas is surrounded by the stomach, intestines, and other organs.

Having to do with the pancreas.

A disease in which malignant (cancer) cells are found in the tissues of the pancreas. Also called exocrine cancer.

A protein secreted by the pancreas that aids in the digestion of food.

PDQ is an online database developed and maintained by the National Cancer Institute. Designed to make the most current, credible, and accurate cancer information available to health professionals and the public, PDQ contains peer-reviewed summaries on cancer treatment, screening, prevention, genetics, complementary and alternative medicine, and supportive care; a registry of cancer clinical trials from around the world; and directories of physicians, professionals who provide genetics services, and organizations that provide cancer care. Most of this information, and more specific information about PDQ, can be found on the NCI's Web site at http://www.cancer.gov/cancertopics/pdq. Also called Physician Data Query.

The tissue that lines the abdominal wall and covers most of the organs in the abdomen.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

Having to do with the functions of the body. When used in the phrase "physiologic age," it refers to an age assigned by general health, as opposed to calendar age.

The organ that nourishes the developing fetus in the uterus.

Having to do with or coming from pigs.

A doctor's order for medicine or another intervention.

In medicine, action taken to decrease the chance of getting a disease or condition. For example, cancer prevention includes avoiding risk factors (such as smoking, obesity, lack of exercise, and radiation exposure) and increasing protective factors (such as getting regular physical activity, staying at a healthy weight, and having a healthy diet).

In medicine, a study or clinical trial in which participants are identified and then followed forward in time.

A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.

The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.

When referring to an experiment or clinical trial, the process by which animal or human subjects are assigned by chance to separate groups that compare different treatments or other interventions. Randomization gives each participant an equal chance of being assigned to any of the groups.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

Removed by surgery.

A procedure that uses surgery to remove tissue or part or all of an organ.

In medicine, an improvement related to treatment.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

In statistics, describes a mathematical measure of difference between groups. The difference is said to be significant if it is greater than what might be expected to happen by chance alone. Also called statistically significant.

The male reproductive cell, formed in the testicle. A sperm unites with an egg to form an embryo.

The extent of a cancer in the body. Staging is usually based on the size of the tumor, whether lymph nodes contain cancer, and whether the cancer has spread from the original site to other parts of the body.

Adding nutrients to the diet.

A set of symptoms or conditions that occur together and suggest the presence of a certain disease or an increased chance of developing the disease.

Having to do with treating disease and helping healing take place.

An organ that is part of the lymphatic system, in which T lymphocytes grow and multiply. The thymus is in the chest behind the breastbone.

A group or layer of cells that work together to perform a specific function.

Having to do with poison or something harmful to the body. Toxic substances usually cause unwanted side effects.

A poison produced by certain animals, plants, or bacteria.

An element found in very small amounts in a given substance. Organisms need certain trace elements to survive.

An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancerous), or malignant (cancerous). Also called neoplasm.

Describes an organ, tissue, or cancer that has not been either partly or completely removed by surgery.

The small, hollow, pear-shaped organ in a woman's pelvis. This is the organ in which a baby grows. Also called womb.

A nutrient that the body needs in small amounts to function and stay healthy. Sources of vitamins are plant and animal food products and dietary supplements. Some vitamins are made in the human body from food products. Vitamins are either fat-soluble (can dissolve in fats and oils) or water-soluble (can dissolve in water). Excess fat-soluble vitamins are stored in the body’s fatty tissue, but excess water-soluble vitamins are removed in the urine. Examples are vitamin A, vitamin C, and vitamin E.