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
Sponsor study identifier
interventional
101
1 country
1
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 31, 2008
Actual (reported)April 2, 2008
Actual (reported)December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
One month pst treatment
To compare changes in patients' moods between Organic germanium versus placebo at the one month follow-up visit
One month follow up
To compare the duration of fatigue between organic germanium and placebo
One month follow up
Organic Germanium tablets 5 times a day
Placebo tablets 3 -5 times per day
Oral organic Germaium tablets on the tongue 3 to 5 times per day as tolerated
Placebo tablets orally 3 - 5 times per day as tolerated
Arizona Oncology Services
Phoenix, Arizona, 85013, United States
Emily Grade, MD
Arizona Oncology Services
First Submitted
March 31, 2008
First Posted
April 2, 2008
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)To further evaluate the toxicity profile of organic germanium using the CTCAE version 3 scale.
one month follow up
To determine the Peak time of fatigue in patients receiving external beam radiotherapy or high dose rate brachytherapy for breast or prostate cancer.
one month follow up
To determine when the patients recover from their radiation induced fatigue
3 month follow-up
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 23, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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