An interventional study of Ensure Plus® and Multivitamin in Bladder Cancer, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Prevention
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.
1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 1,183 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Vanderbilt University is the lead sponsor of 520 studies on the registry; 18 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
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Exclusion Criteria:
Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery
Dietary Supplement: Ensure Plus®
Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery
Dietary Supplement: Multivitamin
Drug page: Ensure Plus
Also known as: Ensure®
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
Time frame: 30 days
Serum markers
The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups
Time frame: 30 days
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
Time frame: 30 days
Tolerability / compliance
The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention
Time frame: 30 days
Complications
The investigators will compare the difference in rate, type and severity of post-operative complications between groups
Time frame: 30 days
Length of stay
The investigators will compare the length of stay following surgery between the two groups
Time frame: 30 days
Readmission rate
The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control
Time frame: 30 days
Mortality
The investigators will compare overall survival between groups over the 30 day postoperative period
Time frame: 30 days
Calories
The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools
Time frame: 30 days
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ensure Plus