Clinical trial NCT02050451: Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: radical cystectomy
urinary diversion
nutrition
oral supplementation
enteral nutrition
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2014-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* inability to tolerate oral supplementation

Primary outcomes:
measure: Hospital-free days (HFDs)
timeFrame: 30 days
Secondary outcomes:
measure: Serum markers
timeFrame: 30 days
measure: Body composition
timeFrame: 30 days
measure: Tolerability / compliance
timeFrame: 30 days
measure: Complications
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Calories
timeFrame: 30 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Department of Urologic Surgery, Vanderbilt University Medical Center
name: Chad R Ritch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Urology, University of Oklahoma Medical Center
name: Michael S Cookson, MD
role: STUDY_DIRECTOR
affiliation: Vanderbilt Center for Human Nutrition
name: Heidi J Silver, PhD, RD
role: STUDY_DIRECTOR
affiliation: Department of Urologic Surgery, Vanderbilt University Medical Center
name: Peter E Clark, MD
role: STUDY_DIRECTOR
affiliation: Department of Urologic Surgery, Vanderbilt University Medical Center
name: Sam S Chang, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.