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:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT03204266
Eligibility Criteria:
Inclusion Criteria:
1. All patients undergoing RC for bladder cancer with urinary diversion at MD Anderson Cancer Center (MDACC). All races and ethnicities will be included
2. Patients must be willing to spend time for the study
3. Patient must provide signed informed consent.
4. Male or female, age \>/= 18 years.
5. Adequate hepatic function: alkaline phosphatase \</= 1.5 x Upper Limit of Normal (ULN); total bilirubin, aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) \</= 1.5 x ULN; international normalized ratio (INR) \<1.3 (or \<3 if on anticoagulant therapy).
Exclusion Criteria:
1. Subjects will be excluded if they do not attend pre-operative clinic dedicated to RC subjects.
2. Subjects with allergies to any supplements.
3. Subjects with galactosemia will be excluded.
4. Subjects may be excluded if they have known autoimmune inflammatory disease. (e.g. rheumatoid arthritis, ulcerative colitis, gout, chronic steroids).
5. Hepatic impairment: alkaline phosphate \> 1.5 x ULN; total bilirubin, AST, and ALT \> 1.5 x ULN; INR \>1.3 (or \>3 if on anticoagulant therapy).
6. Previously unable to tolerate either supplement due to taste or gastrointestinal (GI) side effects.
7. Any active malignancies being treated other than bladder cancer (incidentally found prostate cancer at RC is acceptable).
8. Unwillingness or inability to comply with mandated blood draws.
9. Any previous immunotherapy with immune checkpoint inhibitors such was Nivolumab, Atezolizumab and others in the class
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03204266
Study Brief:
Protocol Section:
NCT03204266