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


Phase 2
18 Years
85 Years
Open (Enrolling)
Male
Fatigue

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Reduction in overall fatigue as measured by Bruera global fatigue severity scale.

Outcome Time Frame:

Within 4 days after completion of intervention (28 days of Red Bull™)

Safety Issue:

No

Principal Investigator

Neil Fleshner, MD, FRCSC, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: University Health Network Research Ethics Board

Study ID:

12-5041-C

NCT ID:

NCT01669460

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Fatigue
  • Fatigue
  • Prostatic Neoplasms

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