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
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
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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.
One month pst treatment
Emily Grade, MD
Arizona Oncology Services
United States: Institutional Review Board
|Arizona Oncology Services||Phoenix, Arizona 85032|