Fatigue Clinical Trial
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
NCT number | NCT01669460 |
Other study ID # | 12-5041-C |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | August 16, 2012 |
Last updated | December 18, 2013 |
Start date | July 2012 |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in overall fatigue as measured by Bruera global fatigue severity scale. | Within 4 days after completion of intervention (28 days of Red Bull™) | No | |
Secondary | 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™) | No |
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