Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

A Pilot Study of Perioperative Oral Nutrition Supplementation to Improve Nutritional Status, Post-operative Complications, Length of Stay and Readmission Rates in Patients Undergoing Radical Cystectomy

The current study is designed to assess the impact of an enriched oral nutritional shake (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a segment of intestine is the standard of care for invasive bladder cancer. This operation has a high complication rate and several studies have shown that this may be directly related to poor nutrition.

The investigators believe that patients who consume an enriched nutritional shake before and after surgery will improve their nutrition status and experience fewer complications, shorter length of stay and less readmissions compared to those who do not.

Patients who are scheduled to undergo elective radical cystectomy will be eligible for enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery and the other will be offered a daily over-the-counter multivitamin for the same period of time. The investigators will follow both groups for up to 30 days after their surgery and compare clinical outcomes such as: complication rates, length of stay, readmission rates and mortality as well as measure serum markers of nutrition status and assess changes in body composition.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Dietary supplement: Multivitamin; Dietary supplement: Ensure Plus®

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution

Exclusion Criteria:

• inability to tolerate oral supplementation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition Intervention; Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery	Dietary supplement: Ensure Plus®; Other Names: Ensure®
Active Comparator: Control; Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery	Dietary supplement: Multivitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital-free days (HFDs)	The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum markers	The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups	30 days
Body composition	The investigators will measure difference in lean body mass and fat mass between intervention and controls using whole body dual energy X-ray absorptiometry (DEXA) scan	30 days
Tolerability / compliance	The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention	30 days
Complications	The investigators will compare the difference in rate, type and severity of post-operative complications between groups	30 days
Length of stay	The investigators will compare the length of stay following surgery between the two groups	30 days
Readmission rate	The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control	30 days
Mortality	The investigators will compare overall survival between groups over the 30 day postoperative period	30 days
Calories	The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools	30 days

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: University of Oklahoma
• Investigators: Principal Investigator: Chad R Ritch, MD, Department of Urologic Surgery, Vanderbilt University Medical Center; Study Director: Michael S Cookson, MD, Department of Urology, University of Oklahoma Medical Center; Study Director: Heidi J Silver, PhD, RD, Vanderbilt Center for Human Nutrition; Study Director: Peter E Clark, MD, Department of Urologic Surgery, Vanderbilt University Medical Center; Study Director: Sam S Chang, MD, Department of Urologic Surgery, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.
• Stimson CJ, Chang SS, Barocas DA, Humphrey JE, Patel SG, Clark PE, Smith JA Jr, Cookson MS. Early and late perioperative outcomes following radical cystectomy: 90-day readmissions, morbidity and mortality in a contemporary series. J Urol. 2010 Oct;184(4):1296-300. doi: 10.1016/j.juro.2010.06.007. Epub 2010 Aug 17.
• Morgan TM, Keegan KA, Barocas DA, Ruhotina N, Phillips SE, Chang SS, Penson DF, Clark PE, Smith JA Jr, Cookson MS. Predicting the probability of 90-day survival of elderly patients with bladder cancer treated with radical cystectomy. J Urol. 2011 Sep;186(3):829-34. doi: 10.1016/j.juro.2011.04.089. Epub 2011 Jul 23.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: nutrition; enteral nutrition; radical cystectomy; urinary diversion; oral supplementation
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: VU-IRB-131560