Clinical trial · Interventional
Oral Supplementation to Enhance Recovery Pilot Study
- 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 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.
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 |
|---|---|---|---|
| Malignant Neoplasms of Urinary Tract | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arginine recovery supplement | Drug | — | UNRESOLVED |
| Omega-3 Fatty Acids | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunonutrition: ARS + Omega-3 Fatty Acids
- description
- Participants take 1 ounce (30mls) of Arginine recovery supplement (ARS) four times daily 5 days preoperatively and 14 days postoperatively. Participants also given omega-3 fatty acids, 1 gram four times a day, 4 grams total per day. This will be started 7 days preoperatively and continued 14 days postoperatively.
- interventionNames
- Drug: Arginine recovery supplement
- Dietary Supplement: Omega-3 Fatty Acids
- type
- NO_INTERVENTION
- label
- No Immunonutrition
- description
- Participants receive regular enhanced recovery after surgery (ERAS)/Optimized Surgical Journey (OSJ) education and follow up.
Primary outcomes (1)
- measure
- Determination if novel immunonutrition regimen is able to be implemented with adequate compliance in Radical Cystectomy (RC) patients: Participant Compliance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available