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Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02050451
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Chad Ritch, Vanderbilt University

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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Dietary Supplement: Ensure Plus® Dietary Supplement: Multivitamin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutrition Intervention
Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery
Dietary Supplement: Ensure Plus®
Other Name: Ensure®

Active Comparator: Control
Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery
Dietary Supplement: Multivitamin



Primary Outcome Measures :
  1. Hospital-free days (HFDs) [ Time Frame: 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 Outcome Measures :
  1. Serum markers [ Time Frame: 30 days ]
    The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups

  2. Body composition [ Time Frame: 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

  3. Tolerability / compliance [ Time Frame: 30 days ]
    The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention

  4. Complications [ Time Frame: 30 days ]
    The investigators will compare the difference in rate, type and severity of post-operative complications between groups

  5. Length of stay [ Time Frame: 30 days ]
    The investigators will compare the length of stay following surgery between the two groups

  6. Readmission rate [ Time Frame: 30 days ]
    The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control

  7. Mortality [ Time Frame: 30 days ]
    The investigators will compare overall survival between groups over the 30 day postoperative period

  8. Calories [ Time Frame: 30 days ]
    The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • inability to tolerate oral supplementation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050451


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
University of Oklahoma
Investigators
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Principal Investigator: Chad R Ritch, MD Department of Urologic Surgery, Vanderbilt University Medical Center
Study Director: Michael S Cookson, MD Department of Urology, University of Oklahoma Medical Center
Study Director: Heidi J Silver, PhD, RD Vanderbilt Center for Human Nutrition
Study Director: Peter E Clark, MD Department of Urologic Surgery, Vanderbilt University Medical Center
Study Director: Sam S Chang, MD Department of Urologic Surgery, Vanderbilt University Medical Center
Additional Information:
Publications:
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Responsible Party: Chad Ritch, Clinical Instructor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02050451    
Other Study ID Numbers: VU-IRB-131560
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by Chad Ritch, Vanderbilt University:
radical cystectomy
urinary diversion
nutrition
oral supplementation
enteral nutrition
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases