Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

Phase 2

Completed

• Conditions: Fatigue
• Interventions: Other: Red Bull™ Sugar-Free Drink

• Registration Number: NCT01669460
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Primary Completion: 2013-07
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Histologically confirmed prostate cancer
• 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

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Exclusion Criteria

• Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Red Bull™ Sugar-Free Drink	Red Bull™ Sugar-Free Drink	Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days

Primary Outcome Measures

Name	Time	Method
Reduction in overall fatigue as measured by Bruera global fatigue severity scale.	Within 4 days after completion of intervention (28 days of Red Bull™)

Secondary Outcome Measures

Name	Time	Method
Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)	Within 4 days after completion of intervention (28 days of Red Bull™)

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada