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

University Health Network, Toronto

Status and phase

Completed

Phase 2

Conditions

Fatigue

Treatments

Other: Red Bull™ Sugar-Free Drink

Study type

Interventional

Funder types

Other

Identifiers

NCT01669460

12-5041-C

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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