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Sponsored by: |
Arizona Oncology Services |
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Information provided by: | Arizona Oncology Services |
ClinicalTrials.gov Identifier: | NCT00651417 |
Participants will be diagnosed with localized prostate or breast cancer and be scheduled to undergo external beam radiation therapy. Participants will either receive a placebo or organic germanium to be taken 5 times a day starting the day of their first radiation and continuing through the 1 month follow-up visit. Weekly Quality of life forms will be completed through the one month follow up visit and then at the 3 month follow up visit. Labs will be done prior to the start of treatment, at the end of treatment and at the one and three month follow-up visits.
Condition | Intervention | Phase |
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Localized Breast Cancer Localized Prostate Cancer Patients Receiving External Beam Radiotherapy |
Dietary Supplement: Organic Germanium Dietary Supplement: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Phase II, Pilot, Randomized, Double-Blind Study Comparing the Effectiveness Organic Germanium to Placebo in Decreasing the Severity of Fatigue in Patients Undergoing Radiation Therapy for Prostae and Bbreast Cancers |
Estimated Enrollment: | 101 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Organic Germanium tablets 5 times a day
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Dietary Supplement: Organic Germanium
Oral organic Germaium tablets on the tongue 3 to 5 times per day as tolerated
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2: Placebo Comparator
Placebo tablets 3 -5 times per day
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Dietary Supplement: Placebo
Placebo tablets orally 3 - 5 times per day as tolerated
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With the increasing public use of complementary medicines, most researchers agree that there is a compelling need to study the safety and efficacy of these agents in humans by means of appropriately designed double-blind, placebo controlled clinical trials. With fatigue affecting 96% of the cancer patient population and little more than life style alterations offered as an intervention, the need to evaluate putative and innovative approaches for fatigue is a high priority. The NIH released a "State of the Science" statement in 2002 which concluded that fatigue is a serious cause of morbidity, being the most prevalent symptom experienced by cancer patients. This expert panel also concluded that the major barrier to effective management of fatigue includes a lack of awareness of this fact, the lack of knowledge of the causes of fatigue, and the lack of proven methods to treat fatigue. Presently, clinical trials evaluating intervention for cancer fatigue are lacking.
Organic germanium literature states that it may be an effective agent for combating fatigue with virtually no toxicities. Since virtually all cancer patients receiving radiation therapy experience fatigue, the use of this drug should be evaluated as an intervention for non-anemic fatigue in breast and prostate cancer patients undergoing a definitive course of radiation therapy. We intend to test whether organic germanium is able to reduce the fatigue experienced by patients undergoing radiation therapy and if this reduction in fatigue correlates to an improvement in quality of life for these patients. Changes in the patients' mood will also be evaluated. We will also collect information on the toxicity profile of Organic germanium and try to determine when the peak fatigue time occurs and possibly when they recover. This information will be utilized to see if a larger study is warranted.
2.0 OBJECTIVES 2.1 Primary: To determine if Organic germanium is effective in decreasing severity of fatigue in patients undergoing definitive radiation therapy for prostate or breast cancer at the one month follow-up visit. 2.2 Secondary 2.2.1 To compare changes in patients' moods between Organic germanium versus placebo at the one month follow-up visit 2.2.2 To compare the duration of fatigue between organic germanium and placebo 2.2.3 To further evaluate the toxicity profile of organic germanium using the CTCAE version 3 scale.
2.2.4 To determine the Peak time of fatigue in patients receiving external beam radiotherapy or high dose rate brachytherapy for breast or prostate cancer. 2.2.5 To determine the tolerability of 5 tablets per day as the dosing schema. 2.2.6 To determine when the patients recover from their radiation induced fatigue
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Terry Thomas, MS, CCRC | 602-240-3383 | theresa@azoncology.com |
United States, Arizona | |
Arizona Oncology Services | Recruiting |
Phoenix, Arizona, United States, 85013 | |
Contact: Terry Thomas, MS, CCRC 602-240-3383 theresa@azoncology.com |
Principal Investigator: | Emily Grade, MD | Arizona Oncology Services |
Responsible Party: | Arizona Oncology Serivces Foundation ( Emily Grade,M.D., Principal Investigator ) |
Study ID Numbers: | Germanium |
Study First Received: | March 31, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00651417 History of Changes |
Health Authority: | United States: Institutional Review Board |
Organic germanium fatigue radiation therapy breast cancer prostate cancer |
Fatigue Prostatic Diseases Genital Neoplasms, Male Skin Diseases Breast Neoplasms |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Skin Diseases |
Breast Neoplasms Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Breast Diseases |