Clinical trial · Interventional
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
NCT01669460CI-TRIAL-00013095completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Red Bull™ Sugar-Free Drink | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Red Bull™ Sugar-Free Drink
- description
- Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
- interventionNames
- Other: Red Bull™ Sugar-Free Drink
Primary outcomes (1)
- measure
- Reduction in overall fatigue as measured by Bruera global fatigue severity scale.
- timeFrame
- Within 4 days after completion of intervention (28 days of Red Bull™)
Secondary outcomes (1)
- measure
- Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)
- timeFrame
- Within 4 days after completion of intervention (28 days of Red Bull™)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.