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Completed

NCT Number: NCT01669460

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.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network

Toronto, Ontario, M5T 1C1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red Bull™ Sugar-Free Drink

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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™)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
First posted
Aug 21, 2012
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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