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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Dietary Supplement: high arginine nutritional supplement (Nestle's Impact AR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult patient seen at one of the aforementioned UPMC facilities who carries a diagnosis of bladder cancer and is considered a candidate for radical cystectomy for treatment. Exclusion Criteria: Minors < 18 years of age, patients not considered surgical candidates, patients who do not go on to undergo radical cystectomy. Patients with Glomerular Filtration Rate (GFR) < 30 will also be excluded in an attempt to limit protein intake of patients with Stage IV and V Chronic Kidney Disease. Diabetic patients will be allowed to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement<br>Subjects will receive high arginine nutritional supplement (Nestle's Impact AR), prior to cystectomy | Dietary Supplement: high arginine nutritional supplement (Nestle's Impact AR)<br>* Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and adherence to supplementation regimen. | Investigator will report on any adverse events from supplementation as well as patient adherence to regimen. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 90-day overall and infectious complication rates. I | Investigator will compare overall, infectious and wound complication rates between the study group and control group | 4 months | 
| Length of hospital stay between study group and control group | The Investigator will compare the length of hospital stay between study group and control group. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary diversion, Bladder Neoplasm, Nutritional Supplement, Cystectomy