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

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


  • Org Study ID: PRO13060027
  • Secondary ID:
  • NCT ID: NCT02655081
  • NCT Alias:
  • Sponsor: University of Pittsburgh - Other
  • Source: University of Pittsburgh

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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: July 2015 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Safety, tolerability and adherence to supplementation regimen."

Primary Outcome 1 - Time Frame: 4 months

Condition:

  • Bladder Cancer

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: No

Official Information

Name: Tatum Tarin, MD

Role: Principal Investigator

Affiliation: Associate Professor of Medicine

Overall Contact

Name: Dawn McBride, RN

Phone: 412-623-2764

Email: mcbridedl@upmc.edu

Location

Facility Status Contact
Shadyside Urology
Pittsburgh, Pennsylvania 15232
United States
Recruiting Dawn McBride, RN
412-623-2764
mcbridedl@upmc.edu