Use of Organic Germanium or Placebo for the Prevention of Radiation Induced Fatigue

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Localized Breast Cancer, Localized Prostate Cancer, Patients Receiving External Beam Radiotherapy

In brief

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.

Key facts

Study ID

NCT00651417

Run by

Arizona Oncology Services

People needed

101

Starts

2005-04-01

Expected to finish

2012-12-01

Last updated by the study team

2011-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Arizona Oncology Services — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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