Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

NCT02050451 | Completed

• 1 other identifier: VU-IRB-131560
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

radical cystectomy; urinary diversion; nutrition; oral supplementation; enteral nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Serum markers

  30 days

• Body composition

  30 days

• Tolerability / compliance

  30 days

• Complications

  30 days

• Length of stay

  30 days

Study Arms (2)

Nutrition Intervention

EXPERIMENTAL

Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery

Dietary Supplement: Ensure Plus®

Control

ACTIVE COMPARATOR

Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery

Dietary Supplement: Multivitamin

Interventions

Ensure Plus® DIETARY_SUPPLEMENT

Also known as: Ensure®

Nutrition Intervention

Multivitamin DIETARY_SUPPLEMENT

Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• inability to tolerate oral supplementation

Sponsors & Collaborators

• Vanderbilt University: lead
• University of Oklahoma: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (3)

• 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

• 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.

  PMID: 20723939 BACKGROUND

• 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.

  PMID: 21788035 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Ensure Plus; Geritol

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

• Chad R Ritch, MD

  Department of Urologic Surgery, Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)