Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

Vanderbilt University

Status: Completed

Conditions: Bladder Cancer

Treatments: Dietary Supplement: Ensure Plus®; Dietary Supplement: Multivitamin

Study type: Interventional

Funder types: Other

Identifiers

NCT02050451

VU-IRB-131560

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• inability to tolerate oral supplementation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Nutrition Intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ensure Plus®

Control

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Multivitamin