Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT01669460
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01669460
Study Brief:
Protocol Section:
NCT01669460