Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
NCT ID: NCT01669460
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days
Interventions
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Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days
Eligibility Criteria
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Inclusion Criteria
* Currently receiving LHRH-agonist therapy for greater than 6 months
* Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale
* Able to swallow Red Bull™ Sugar-Free Drink
* Life expectancy of at least 1 year
* Able to read and write in English
* Willing to limit consumption of alcohol to one drink per day
Exclusion Criteria
* Myocardial infarction within past 6 months
* Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders
* Evidence of drug or alcohol abuse
* Known hypersensitivity to caffeine
* Known history of liver and kidney insufficiencies
* Known contraindications to Red Bull™ use
18 Years
85 Years
MALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Neil Fleshner, MD, FRCSC, MPH
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University Health Network
Toronto, Ontario, Canada
Countries
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Other Identifiers
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12-5041-C
Identifier Type: -
Identifier Source: org_study_id