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

December 18, 2013 updated by: University Health Network, Toronto

A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1C1
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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™)
Within 4 days after completion of intervention (28 days of Red Bull™)

Secondary Outcome Measures

Outcome Measure
Time Frame
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™)
Within 4 days after completion of intervention (28 days of Red Bull™)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Neil Fleshner, MD, FRCSC, MPH, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (ESTIMATE)

August 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-5041-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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