Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy — IMPACT  

Bladder Cancer Clinical Trial

Official title: Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy

Status Completed

Clinical Trial Summary

To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with a preoperative high-arginine nutritional supplement. The investigator will measure patient adherence to the regimen, tolerability of the supplement and feasibility of supplementation. Secondary outcome measures will include differences in length of stay and complication rate between groups.

Clinical Trial Description

The purpose of this study is to investigate the use of a high-arginine protein supplement prior to surgery for patients undergoing radical cystectomy for treatment of bladder cancer. As many as 50% of patients who undergo radical cystectomy experience a postoperative complication, and poor preoperative nutritional status is known to increase the risk of complications. Preoperative use of a high-arginine protein shake has been shown to reduce the risk of postoperative complications for patients undergoing surgery for colon cancer, and this study seeks to determine whether this is also true for patients undergoing radical cystectomy for bladder cancer.

Subjects will drink four protein shakes (Nestle Impact AR) per day for 5-7 days prior to radical cystectomy. Shakes will be provided to patients free of charge. On the date of surgery, subjects will turn in a log of shake consumption. Surgery will then proceed in typical fashion, and no changes will be made to surgery or postoperative care. Clinical outcomes for the first 90 postoperative days will be collected. Patient outcomes will be compared to those of contemporary controls who do not undergo supervised nutritional supplementation. Primary study outcome is to assess safety, tolerability and adherence to supplementation regimen. Secondary outcomes include differences in complication rates and length of postoperative hospital stay between groups. ;

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

• NCT number: NCT02655081
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Completion date: December 2016