Back to resultsStudy of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
Primary Purpose
Fatigue
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Red Bull™ Sugar-Free Drink
Sponsored by
About this trial
This is an interventional supportive care trial for Fatigue
Eligibility Criteria
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
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
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Red Bull™ Sugar-Free Drink
Arm Description
Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
Outcomes
Primary Outcome Measures
Reduction in overall fatigue as measured by Bruera global fatigue severity scale.
Secondary Outcome Measures
Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)
Full Information
NCT ID
NCT01669460
First Posted
August 16, 2012
Last Updated
December 18, 2013
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01669460
Brief Title
Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
Official Title
A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Red Bull™ Sugar-Free Drink
Arm Type
Experimental
Arm Description
Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
Intervention Type
Other
Intervention Name(s)
Red Bull™ Sugar-Free Drink
Intervention Description
Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days
Primary Outcome Measure Information:
Title
Reduction in overall fatigue as measured by Bruera global fatigue severity scale.
Time Frame
Within 4 days after completion of intervention (28 days of Red Bull™)
Secondary Outcome Measure Information:
Title
Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)
Time Frame
Within 4 days after completion of intervention (28 days of Red Bull™)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Fleshner, MD, FRCSC, MPH
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1C1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
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