Overview
Questions and Answers About 714-X
Changes To This Summary (07/24/2006)
General CAM Information
Evaluation of CAM Approaches
Questions to Ask Your Health Care Provider About CAM
To Learn More About CAM

Overview

• The main ingredient of 714-X is camphor, which comes from the wood and bark of the camphor tree (see Question 1 ¹).



• It is claimed that 714-X helps the immune system fight cancer (see Question 3 ²).



• No study of 714-X has been published in a peer-reviewed scientific journal to show it is safe or effective in treating cancer (see Question 6 ³).



• 714-X is not approved by the US Food and Drug Administration for use in the United States (see Question 8 ⁴).

Questions and Answers About 714-X

1. What is 714-X?

   714-X is a chemical compound that contains camphor, a natural substance that comes from the wood and bark of the camphor tree. Nitrogen, water, and salts are added to camphor to make 714-X.

2. What is the history of the discovery and use of 714-X as a complementary and alternative treatment for cancer?

   714-X was developed in the 1960s in Canada, where it is still being made. Patients in Canada can get 714-X only from a doctor, for compassionate use (giving a treatment to patients before it is approved, because they have a life-threatening disease and there is no drug or other therapy to treat the disease). 714-X is used in Mexico and some western European countries. It is not approved by the US Food and Drug Administration (FDA) for use in the United States (see Question 8 ⁴).

3. What is the theory behind the claim that 714-X is useful in treating cancer?

   The development of 714-X was based on the theory that there are tiny living things in the blood called somatids. According to this theory, some types of somatids are found only in the blood of people who have cancer or other serious diseases. These types of somatids are said to make growth hormones that cause cells to grow without control. The makers of 714-X state that by looking at the number and type of somatids in the blood, doctors can see if cancer is starting to form or can diagnose cancer and predict where the cancer will spread.

   The theory states that cancer cells trap nitrogen needed by normal cells and make a toxic substance that weakens the immune system. 714-X is reported to help the body fight cancer cells in these ways:

   • The camphor in 714-X is said to prevent cancer cells from taking nitrogen from the body's normal cells.
   • 714-X is also said to help the immune system by increasing the flow of lymph, the colorless fluid that travels through the body carrying white blood cells that help fight infection and disease.

   Some research studies are published in scientific journals. Most scientific journals have experts who review research reports before they are published, to make sure that the evidence and conclusions are sound. This is called peer review. Studies published in peer-reviewed scientific journals are considered to be better evidence. No studies have been published in peer-reviewed scientific journals to support the theory of somatids in the development of cancer. Research on the use of 714-X as a cancer treatment is discussed in Question 5 ⁵ and Question 6 ³.

4. How is 714-X administered?

   714-X is usually given by injection near the lymph nodes in the groin. In some patients with lung or oral cancer, 714-X can be sprayed into the nose using a nebulizer (a device that turns liquid into a fine spray). The makers of 714-X do not recommend injecting it into a vein (intravenously) or taking it by mouth.

   The makers of 714-X suggest the following:

   • 714-X is more effective if given early in the disease, before chemotherapy or radiation therapy is begun.
   • 714-X can be used along with conventional treatments.
   • Vitamin B ₁₂ supplements, vitamin E supplements, shark cartilage, and alcohol should not be used during treatment with 714-X.
5. Have any preclinical (laboratory or animal) studies been conducted using 714-X?

   Research in a laboratory or using animals is done to find out if a drug, procedure, or treatment is likely to be useful in humans. Animal tumor models are used to learn how a cancer may progress and to test new treatments. These preclinical studies are done before any testing in humans is begun.

   No laboratory studies of the safety and/or effectiveness of 714-X have been published in a peer-reviewed scientific journal. A few animal experiments have been done, but the results of these experiments have not been reported in scientific journals. The animal studies used a lymphosarcoma tumor model in rats and lymphoma tumor models in dogs and cows. 714-X was not found to be effective against cancer in these studies.

6. Have any clinical trials (research studies with people) of 714-X been conducted?

   No clinical trials or other studies with cancer patients have been published in peer-reviewed scientific journals to support the safety or effectiveness of 714-X. A number of anecdotal reports (incomplete descriptions of the medical and treatment history of one or more patients) and testimonials (personal reports from people who claim to have been helped or cured by the product) have been published in newspapers and other nonmedical literature. The National Cancer Institute (NCI) reviewed the records of some cancer patients who used 714-X. This review was done to decide if NCI should begin a clinical trial of the product. Not enough information was available to support recommending a trial. NCI wants to hear from other patients who have used 714-X for the treatment of cancer. See the notice ⁶ on the Office of Cancer Complementary and Alternative Medicine Web site ⁷.

7. Have any side effects or risks been reported from 714-X?

   The makers of 714-X claim that it is not harmful to humans. The reported side effects of treatment with 714-X are redness, tenderness, and swelling at the injection site.

8. Is 714-X approved by the FDA as a cancer treatment in the United States?

   The FDA has not approved 714-X for use in the United States.

Changes To This Summary (07/24/2006)

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.

General CAM Information

Complementary and alternative medicine (CAM)—also referred to as integrative medicine—includes a broad range of healing philosophies, approaches, and therapies. A therapy is generally called complementary when it is used in addition to conventional treatments; it is often called alternative when it is used instead of conventional treatment. (Conventional treatments are those that are widely accepted and practiced by the mainstream medical community.) Depending on how they are used, some therapies can be considered either complementary or alternative. Complementary and alternative therapies are used in an effort to prevent illness, reduce stress, prevent or reduce side effects and symptoms, or control or cure disease.

Unlike conventional treatments for cancer, complementary and alternative therapies are often not covered by insurance companies. Patients should check with their insurance provider to find out about coverage for complementary and alternative therapies.

Cancer patients considering complementary and alternative therapies should discuss this decision with their doctor, nurse, or pharmacist as they would any therapeutic approach, because some complementary and alternative therapies may interfere with their standard treatment or may be harmful when used with conventional treatment.

Evaluation of CAM Approaches

It is important that the same rigorous scientific evaluation used to assess conventional approaches be used to evaluate CAM therapies. The National Cancer Institute (NCI) and the National Center for Complementary and Alternative Medicine (NCCAM) are sponsoring a number of clinical trials (research studies) at medical centers to evaluate CAM therapies for cancer.

Conventional approaches to cancer treatment have generally been studied for safety and effectiveness through a rigorous scientific process that includes clinical trials with large numbers of patients. Less is known about the safety and effectiveness of complementary and alternative methods. Few CAM therapies have undergone rigorous evaluation. A small number of CAM therapies originally considered to be purely alternative approaches are finding a place in cancer treatment—not as cures, but as complementary therapies that may help patients feel better and recover faster. One example is acupuncture. According to a panel of experts at a National Institutes of Health (NIH) Consensus Conference in November 1997, acupuncture has been found to be effective in the management of chemotherapy-associated nausea and vomiting and in controlling pain associated with surgery. In contrast, some approaches, such as the use of laetrile, have been studied and found ineffective or potentially harmful.

The NCI Best Case Series Program ⁸, which was started in 1991, is one way CAM approaches that are being used in practice are being investigated. The program is overseen by the NCI’s Office of Cancer Complementary and Alternative Medicine (OCCAM). Health care professionals who offer alternative cancer therapies submit their patients’ medical records and related materials to OCCAM. OCCAM conducts a critical review of the materials and develops follow-up research strategies for approaches deemed to warrant NCI-initiated research.

Questions to Ask Your Health Care Provider About CAM

When considering complementary and alternative therapies, patients should ask their health care provider the following questions:

• What side effects can be expected?
• What are the risks associated with this therapy?
• Do the known benefits outweigh the risks?
• What benefits can be expected from this therapy?
• Will the therapy interfere with conventional treatment?
• Is this therapy part of a clinical trial?
• If so, who is sponsoring the trial?
• Will the therapy be covered by health insurance?

To Learn More About CAM

National Center for Complementary and Alternative Medicine (NCCAM)

The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) facilitates research and evaluation of complementary and alternative practices, and provides information about a variety of approaches to health professionals and the public.

NCCAM Clearinghouse

Post Office Box 7923 Gaithersburg, MD 20898–7923

Telephone: 1–888–644–6226 (toll free) 301–519–3153 (for International callers)

TTY (for deaf and hard of hearing callers): 1–866–464–3615

Fax: 1–866–464–3616

E-mail: info@nccam.nih.gov

Web site: http://nccam.nih.gov

CAM on PubMed

NCCAM and the NIH National Library of Medicine (NLM) jointly developed CAM on PubMed, a free and easy-to-use search tool for finding CAM-related journal citations. As a subset of the NLM's PubMed bibliographic database, CAM on PubMed features more than 230,000 references and abstracts for CAM-related articles from scientific journals. This database also provides links to the Web sites of over 1,800 journals, allowing users to view full-text articles. (A subscription or other fee may be required to access full-text articles.) CAM on PubMed is available through the NCCAM Web site ⁹. It can also be accessed through NLM PubMed ¹⁰ bibliographic database by selecting the "Limits" tab and choosing "Complementary Medicine" as a subset.

Office of Cancer Complementary and Alternative Medicine

The NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) coordinates the activities of the NCI in the area of complementary and alternative medicine (CAM). OCCAM supports CAM cancer research and provides information about cancer-related CAM to health providers and the general public via the NCI Web site ⁷.

National Cancer Institute (NCI) Cancer Information Service

U.S. residents may call the NCI Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237) Monday through Friday from 9:00 am to 4:30 pm. Deaf and hearing impaired callers with TTY equipment may call 1-800-332-8615. A trained Cancer Information Specialist is available to answer your questions.

Food and Drug Administration

The Food and Drug Administration (FDA) regulates drugs and medical devices to ensure that they are safe and effective.

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Telephone: 1–888–463–6332 (toll free)

Web site: http://www.fda.gov/

Federal Trade Commission

The Federal Trade Commission (FTC) enforces consumer protection laws. Publications available from the FTC include:

• Who Cares: Sources of Information About Health Care Products and Services
• Fraudulent Health Claims: Don’t Be Fooled

Consumer Response Center

Federal Trade Commission

CRC-240

Washington, DC 20580

Telephone: 1-877-FTC-HELP (1-877-382-4357) (toll free)

TTY (for deaf and hearing impaired callers): 202-326-2502

Web site: http://www.ftc.gov/

Glossary Terms

A chemical substance found in beer, wine, and liquor. Alcohol is also found in some medicines, mouthwashes, essential oils (scented liquid taken from plants), and household products.

An incomplete description of the medical and treatment history of one or more patients. Anecdotal reports may be published in places other than peer-reviewed, scientific journals.

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 substance that comes from the wood and bark of the camphor tree or is made in the laboratory. It has a very unique smell and taste and is used in commercial products (for example, mothballs). Camphor is used in topical anti-infective and anti-pruritic (anti-itching) agents.

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.

A tough, flexible tissue that lines joints and gives structure to the nose, ears, larynx, and other parts of the body.

Treatment with drugs that kill cancer cells.

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.

In science, a substance that is made up of more than one ingredient.

A currently accepted and widely used treatment for a certain type of disease, based on the results of past research. Also called conventional therapy.

To heal or restore health; a treatment to restore health.

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

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.

Liquid.

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.

The area where the thigh meets the abdomen.

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

Invasion and multiplication of germs in the body. Infections can occur in any part of the body and can spread throughout the body. The germs may be bacteria, viruses, yeast, or fungi. They can cause a fever and other problems, depending on where the infection occurs. When the body’s natural defense system is strong, it can often fight the germs and prevent infection. Some cancer treatments can weaken the natural defense system.

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

Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called I.V..

Research done in a laboratory. These studies may use test tubes or animals to find out if a drug, procedure, or treatment is likely to be useful. Laboratory studies take place before any testing is done in humans.

Cancer that forms in tissues of the lung, usually in the cells lining air passages. The two main types are small cell lung cancer and non-small cell lung cancer. These types are diagnosed based on how the cells look under a microscope.

The clear fluid that travels through the lymphatic system and carries cells that help fight infections and other diseases. Also called lymphatic fluid.

A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called lymph gland.

Cancer that begins in cells of the immune system. There are two basic categories of lymphomas. One kind is Hodgkin lymphoma, which is marked by the presence of a type of cell called the Reed-Sternberg cell. The other category is non-Hodgkin lymphomas, which includes a large, diverse group of cancers of immune system cells. Non-Hodgkin lymphomas can be further divided into cancers that have an indolent (slow-growing) course and those that have an aggressive (fast-growing) course. These subtypes behave and respond to treatment differently. Both Hodgkin and non-Hodgkin lymphomas can occur in children and adults, and prognosis and treatment depend on the stage and the type of cancer.

An obsolete term for a malignant tumor of lymphatic tissue.

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.

A device used to turn liquid into a fine spray.

Cancer that forms in tissues of the lip or mouth. This includes the front two thirds of the tongue, the upper and lower gums, the lining inside the cheeks and lips, the bottom of the mouth under the tongue, the bony top of the mouth, and the small area behind the wisdom teeth.

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.

Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.

In medicine, the course of a disease, such as cancer, as it becomes worse or spreads in the body.

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.

A person who has studied science, especially one who is active in a particular field of investigation.

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.

Adding nutrients to the diet.

Information provided by an individual who claims to have been helped or cured by a particular product. The information provided lacks the necessary elements to be evaluated in a rigorous and scientific manner and is not used in the scientific literature.

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

Cells, tissues, or animals used to study the development and progression of cancer, and to test new treatments before they are given to humans. Animals with transplanted human tumors or other tissues are called xenograft models.

A nutrient in the vitamin B complex that the body needs in small amounts to function and stay healthy. Vitamin B12 helps make red blood cells, DNA, RNA, energy, and tissues, and keeps nerve cells healthy. It is found in liver, meat, eggs, poultry, shellfish, milk, and milk products. Vitamin B12 is water-soluble (can dissolve in water) and must be taken in every day. Not enough vitamin B12 can cause certain types of anemia (a condition in which the number of red blood cells is below normal) and neurologic disorders. It is being studied with folate in the prevention and treatment of some types of cancer. Also called cobalamin and cyanocobalamin.

A nutrient that the body needs in small amounts to function and stay healthy. Vitamin E helps prevent cell damage caused by free radicals (highly reactive chemicals). It is fat-soluble (can dissolve in fats and oils) and is found in seeds, nuts, leafy vegetables, and vegetable oils. Not enough vitamin E can result in infertility (the inability to produce children). It is being studied in the prevention and treatment of some types of cancer. Vitamin E is a type of antioxidant.

Refers to a blood cell that does not contain hemoglobin. White blood cells include lymphocytes, neutrophils, eosinophils, macrophages, and mast cells. These cells are made by bone marrow and help the body fight infections and other diseases. Also called WBC.