Recruiting
Phase 2

Organic Germanium

Sponsor:

Arizona Oncology Services

Code:

NCT00651417

Conditions

Localized Breast Cancer

Localized Prostate Cancer

Patients Receiving External Beam Radiotherapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Organic Germanium

Placebo

Study Details

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 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.

Conditions

Localized Breast Cancer

Localized Prostate Cancer

Patients Receiving External Beam Radiotherapy

Study ID

NCT00651417

Start date

Apr, 2005

Status verified date

Jun, 2011

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologically-confirmed diagnosis of breast (females only) or prostate cancer
2. Zubrod performance status of 0-1.
3. Patients must be ≥ 18 years of age.
4. Scheduled to undergo definitive radiation therapy (either brachytherapy or external beam)
5. 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.
6. Hgb ≥ 10 g/dl, BUN < 25 mg and creatinine < 1.5 mg
7. Patient must be able to comply with treatment regimen.
8. Patient must complete the pre-treatment quality of life questionnaires.
9. 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.
10. Patients must sign study-specific informed consent prior to study entry.

Exclusion Criteria:

1. Known allergies or reactions to Organic germanium
2. Prior irradiation other than basal cell cancer of skin
3. Current or past history of metastasis
4. 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
5. Current use of corticosteroids or erythropoietin
6. Patients currently taking Organic germanium, or who have taken Organic germanium within the past three months
7. Pregnant or lactating women, as treatment involves unforeseeable risks to the participant and to the embryo or fetus
8. Patients who are unable to complete quality of life questionnaires
9. Male breast cancer patients

Study Design

Enrollment

101 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 1

Organic Germanium tablets 5 times a day

placebo comparator: 2

Placebo tablets 3 -5 times per day

Interventions

Organic Germanium

Oral organic Germaium tablets on the tongue 3 to 5 times per day as tolerated

Placebo

Placebo tablets orally 3 - 5 times per day as tolerated

Primary outcome measure

  • 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. [ Time Frame: One month pst treatment ]

Central Contacts and Locations

Central contacts

Locations

Arizona Oncology Services

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

More Information

Sponsor

Arizona Oncology Services

Last update posted

Jun 23, 2011

Last verified

Jun, 2011

Keywords

  • Organic germanium
  • fatigue
  • radiation therapy
  • breast cancer
  • prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arizona Oncology Services on 2011-06-23.