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

NCT00651417 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2011-06-23

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Organic Germanium

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

DIETARY_SUPPLEMENT

Placebo

Placebo tablets orally 3 - 5 times per day as tolerated

Sponsors & Collaborators

  • Arizona Oncology Services

    lead OTHER

Principal Investigators

  • Emily Grade, MD · Arizona Oncology Services

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00651417 on ClinicalTrials.gov