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Oral Supplementation to Enhance Recovery Pilot Study

NCT03204266 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-08-24

No results posted yet for this study

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.

Conditions

  • Malignant Neoplasms of Urinary Tract

Interventions

DRUG

Arginine recovery supplement

Participants take 1 ounce (30mls) of Arginine recovery supplement four times daily 5 days preoperatively and 14 days postoperatively.

DIETARY_SUPPLEMENT

Omega-3 Fatty Acids

Participants 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Neema Navai, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2022-05-25
Completion
2022-05-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204266 on ClinicalTrials.gov