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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01669460

Enrollment

Registered

2012-08-21

Start date

2012-07-31

Completion date

Unknown

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue

Brief summary

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.

Interventions

OTHERRed Bull™ Sugar-Free Drink

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Reduction in overall fatigue as measured by Bruera global fatigue severity scale.	Within 4 days after completion of intervention (28 days of Red Bull™)

Secondary

Measure	Time frame
Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)	Within 4 days after completion of intervention (28 days of Red Bull™)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026