Overview

Oral Supplementation to Enhance Recovery Pilot Study

Status:
Active, not recruiting

Trial end date:
2020-08-31

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to learn the supplements Pro-Stat (which has l-arginine and also contains protein) and omega-3 fatty acids will be well tolerated in patients who have radical cystectomy for bladder cancer. Researchers also want to learn how these medications affect inflammation and recovery for these surgical patients. This is an investigational study. Pro-Stat is not FDA-approved to treat any specific condition or disease. Omega-3 fatty acids are FDA-approved to treat high triglyceride levels. Their use to treat inflammation and help improve recovery after bladder cancer surgery is investigational. The study doctor can explain how the supplements are designed to work. Up to 46 participants will be enrolled in this study. All will take part at MD Anderson.

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

National Cancer Institute (NCI)

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 total bilirubin, aspartate aminotransferase (AST), and Alanine aminotransferase (ALT)
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