Clinical trial · Interventional
Use of Organic Germanium or Placebo for the Prevention of Radiation Induced Fatigue
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Localized Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Patients Receiving External Beam Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Organic Germanium | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Organic Germanium tablets 5 times a day
- interventionNames
- Dietary Supplement: Organic Germanium
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo tablets 3 -5 times per day
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available