Bladder Cancer
Conditions
Keywords
radical cystectomy, urinary diversion, nutrition, oral supplementation, enteral nutrition
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.
Interventions
DIETARY_SUPPLEMENTEnsure Plus®
DIETARY_SUPPLEMENTMultivitamin
Sponsors
University of Oklahoma
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution
Exclusion criteria
* inability to tolerate oral supplementation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-free days (HFDs) | 30 days | The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 30 days | 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 |
| Tolerability / compliance | 30 days | The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention |
| Complications | 30 days | The investigators will compare the difference in rate, type and severity of post-operative complications between groups |
| Serum markers | 30 days | The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups |
| Readmission rate | 30 days | The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control |
| Mortality | 30 days | The investigators will compare overall survival between groups over the 30 day postoperative period |
| Calories | 30 days | The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools |
| Length of stay | 30 days | The investigators will compare the length of stay following surgery between the two groups |
Countries
United States
Outcome results
None listed