Clinical trial NCT02655081: Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy
Official title: Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Urinary diversion
Bladder Neoplasm
Nutritional Supplement
Cystectomy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety, tolerability and adherence to supplementation regimen."
timeFrame: 4 months
Secondary outcomes:
measure: Incidence of 90-day overall and infectious complication rates. I
timeFrame: 4 months
measure: Length of hospital stay between study group and control group
timeFrame: 4 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Shadyside Urology
state: Pennsylvania
Study officials:
affiliation: Associate Professor of Medicine
name: Tatum Tarin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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