Status:
UNKNOWN
Use of Organic Germanium or Placebo for the Prevention of Radiation Induced Fatigue
Lead Sponsor:
Arizona Oncology Services
Conditions:
Localized Breast Cancer
Localized Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- Histologically-confirmed diagnosis of breast (females only) or prostate cancer
- Zubrod performance status of 0-1.
- Patients must be ≥ 18 years of age.
- Scheduled to undergo definitive radiation therapy (either brachytherapy or external beam)
- Patients may have received or be receiving hormonal therapy. Prior chemotherapy is allowed as long as the patient has recovered from any toxicity. Planned future chemotherapy is also allowed after the one month evaluation.
- Hgb ≥ 10 g/dl, BUN \< 25 mg and creatinine \< 1.5 mg
- Patient must be able to comply with treatment regimen.
- Patient must complete the pre-treatment quality of life questionnaires.
- Women of childbearing potential must have a pre-treatment pregnancy test; women of childbearing potential and men able to father children must use non-hormonal-based birth control while on study.
- Patients must sign study-specific informed consent prior to study entry.
Exclusion
- Known allergies or reactions to Organic germanium
- Prior irradiation other than basal cell cancer of skin
- Current or past history of metastasis
- Current history of uncontrolled hypertension, insulin dependent or uncontrolled diabetes, cardiovascular disease unless controlled and stable for 6 months or more, bleeding disorders, or autoimmune disorders such as fibromyalgia, chronic fatigue syndrome or lupus
- Current use of corticosteroids or erythropoietin
- Patients currently taking Organic germanium, or who have taken Organic germanium within the past three months
- Pregnant or lactating women, as treatment involves unforeseeable risks to the participant and to the embryo or fetus
- Patients who are unable to complete quality of life questionnaires
- Male breast cancer patients
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00651417
Start Date
April 1 2005
End Date
December 1 2012
Last Update
June 23 2011
Active Locations (1)
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1
Arizona Oncology Services
Phoenix, Arizona, United States, 85013