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1 for Breast Cancer
Phase 2
Waitlist Available
Led By Emily Grade, MD
Research Sponsored by Arizona Oncology Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically-confirmed diagnosis of breast (females only) or prostate cancer
Zubrod performance status of 0-1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month pst treatment
Awards & highlights
Study 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.
Eligible Conditions
- Breast Cancer
- Prostate Cancer
- External Beam Radiotherapy
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
To compare changes in patients' moods between Organic germanium versus placebo at the one month follow-up visit
To compare the duration of fatigue between organic germanium and placebo
To determine the Peak time of fatigue in patients receiving external beam radiotherapy or high dose rate brachytherapy for breast or prostate cancer.
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: 1Active Control1 Intervention
Organic Germanium tablets 5 times a day
Group II: 2Placebo Group1 Intervention
Placebo tablets 3 -5 times per day
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Who is running the clinical trial?
Arizona Oncology ServicesLead Sponsor
Emily Grade, MDPrincipal InvestigatorArizona Oncology Services
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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