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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669460
First Posted: August 21, 2012
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose
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.

Condition Intervention Phase
Fatigue Other: Red Bull™ Sugar-Free Drink Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 Measures:
  • 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™) ]

Enrollment: 20
Study Start Date: July 2012
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
Other: Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669460


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5T 1C1
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Neil Fleshner, MD, FRCSC, MPH University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01669460     History of Changes
Other Study ID Numbers: 12-5041-C
First Submitted: August 16, 2012
First Posted: August 21, 2012
Last Update Posted: December 19, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Fatigue
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms