Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050451
• Other study ID #: VU-IRB-131560
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: March 27, 2017
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• inability to tolerate oral supplementation

Related Conditions & MeSH terms

• Bladder Cancer
• Postoperative Complications
• Urinary Bladder Neoplasms

Intervention

Dietary Supplement:
• Ensure Plus®

• Multivitamin

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	University of Oklahoma

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum markers	The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups	30 days
Secondary	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
Secondary	Tolerability / compliance	The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention	30 days
Secondary	Complications	The investigators will compare the difference in rate, type and severity of post-operative complications between groups	30 days
Secondary	Length of stay	The investigators will compare the length of stay following surgery between the two groups	30 days
Secondary	Readmission rate	The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control	30 days
Secondary	Mortality	The investigators will compare overall survival between groups over the 30 day postoperative period	30 days
Secondary	Calories	The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools	30 days

External Links

•   Vanderbilt University Center for Human Nutrition
•   Vanderbilt University Department of Urologic Surgery