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

NCT02655081 | Completed Phase 2

• 1 other identifier: PRO13060027
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Urinary diversion; Bladder Neoplasm; Nutritional Supplement; Cystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of 90-day overall and infectious complication rates. I

  4 months

• Length of hospital stay between study group and control group

  4 months

Study Arms (1)

Dietary supplement

EXPERIMENTAL

Subjects will receive high arginine nutritional supplement (Nestle's Impact AR), prior to cystectomy

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

Interventions

high arginine nutritional supplement (Nestle's Impact AR) DIETARY_SUPPLEMENT

Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy

Dietary supplement

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Shadyside Urology

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (11)

• Braga M, Gianotti L, Radaelli G, Vignali A, Mari G, Gentilini O, Di Carlo V. Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial. Arch Surg. 1999 Apr;134(4):428-33. doi: 10.1001/archsurg.134.4.428.

  PMID: 10199318 BACKGROUND

• Shabsigh A, Korets R, Vora KC, Brooks CM, Cronin AM, Savage C, Raj G, Bochner BH, Dalbagni G, Herr HW, Donat SM. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol. 2009 Jan;55(1):164-74. doi: 10.1016/j.eururo.2008.07.031. Epub 2008 Jul 18.

  PMID: 18675501 BACKGROUND

• Lee CT, Madii R, Daignault S, Dunn RL, Zhang Y, Montie JE, Wood DP Jr. Cystectomy delay more than 3 months from initial bladder cancer diagnosis results in decreased disease specific and overall survival. J Urol. 2006 Apr;175(4):1262-7; discussion 1267. doi: 10.1016/S0022-5347(05)00644-0.

  PMID: 16515975 BACKGROUND

• Gibbs J, Cull W, Henderson W, Daley J, Hur K, Khuri SF. Preoperative serum albumin level as a predictor of operative mortality and morbidity: results from the National VA Surgical Risk Study. Arch Surg. 1999 Jan;134(1):36-42. doi: 10.1001/archsurg.134.1.36.

  PMID: 9927128 BACKGROUND

• Gregg JR, Cookson MS, Phillips S, Salem S, Chang SS, Clark PE, Davis R, Stimson CJ Jr, Aghazadeh M, Smith JA Jr, Barocas DA. Effect of preoperative nutritional deficiency on mortality after radical cystectomy for bladder cancer. J Urol. 2011 Jan;185(1):90-6. doi: 10.1016/j.juro.2010.09.021. Epub 2010 Nov 12.

  PMID: 21074802 BACKGROUND

• Hollenbeck BK, Miller DC, Taub DA, Dunn RL, Khuri SF, Henderson WG, Montie JE, Underwood W 3rd, Wei JT. The effects of adjusting for case mix on mortality and length of stay following radical cystectomy. J Urol. 2006 Oct;176(4 Pt 1):1363-8. doi: 10.1016/j.juro.2006.06.015.

  PMID: 16952633 BACKGROUND

• Waitzberg DL, Saito H, Plank LD, Jamieson GG, Jagannath P, Hwang TL, Mijares JM, Bihari D. Postsurgical infections are reduced with specialized nutrition support. World J Surg. 2006 Aug;30(8):1592-604. doi: 10.1007/s00268-005-0657-x.

  PMID: 16794908 BACKGROUND

• Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.

  PMID: 12464864 BACKGROUND

• Schiesser M, Kirchhoff P, Muller MK, Schafer M, Clavien PA. The correlation of nutrition risk index, nutrition risk score, and bioimpedance analysis with postoperative complications in patients undergoing gastrointestinal surgery. Surgery. 2009 May;145(5):519-26. doi: 10.1016/j.surg.2009.02.001. Epub 2009 Mar 27.

  PMID: 19375611 BACKGROUND

• Oh CA, Kim DH, Oh SJ, Choi MG, Noh JH, Sohn TS, Bae JM, Kim S. Nutritional risk index as a predictor of postoperative wound complications after gastrectomy. World J Gastroenterol. 2012 Feb 21;18(7):673-8. doi: 10.3748/wjg.v18.i7.673.

  PMID: 22363139 BACKGROUND

• Giger U, Buchler M, Farhadi J, Berger D, Husler J, Schneider H, Krahenbuhl S, Krahenbuhl L. Preoperative immunonutrition suppresses perioperative inflammatory response in patients with major abdominal surgery-a randomized controlled pilot study. Ann Surg Oncol. 2007 Oct;14(10):2798-806. doi: 10.1245/s10434-007-9407-7. Epub 2007 Jul 15.

  PMID: 17632760 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Tatum Tarin, MD

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: January 13, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

US (1)