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

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University of Pittsburgh

Status and phase

Completed
Phase 2

Conditions

Bladder Cancer

Treatments

Dietary Supplement: high arginine nutritional supplement (Nestle's Impact AR)

Study type

Interventional

Funder types

Other

Identifiers

NCT02655081
PRO13060027

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

Dietary supplement
Experimental group
Description:
Subjects will receive high arginine nutritional supplement (Nestle's Impact AR), prior to cystectomy
Treatment:
Dietary Supplement: high arginine nutritional supplement (Nestle's Impact AR)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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