Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study

This study is currently recruiting participants.
Verified July 2013 by University of Kansas
Sponsor:
Collaborators:
American Cancer Society, Inc.
Nestle HealthCare Nutrition
Information provided by (Responsible Party):
Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01868087
First received: May 29, 2013
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications.


Condition Intervention Phase
Bladder Cancer
Radical Cystectomy
Urinary Bladder Neoplasms
Surgery
Dietary Supplement: Boost Plus®
Dietary Supplement: Impact Advanced Recovery®
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Impact Advanced Recovery® for Radical Cystectomy (RC) Patients

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Immune and Inflammation Response [ Time Frame: Change from Baseline to Day 30 ] [ Designated as safety issue: Yes ]
    Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.


Secondary Outcome Measures:
  • preservation of body weight and fat free mass (FFM) [ Time Frame: Change from Baseline to 30 Days ] [ Designated as safety issue: No ]
    measure of body weight and fat free mass between groups over course of the study

  • count of infections after surgery [ Time Frame: Change from Baseline to 30 Days ] [ Designated as safety issue: Yes ]
    count of total number of infections affecting study participants

  • hospital readmission rate [ Time Frame: Change from Baseline to 30 Days ] [ Designated as safety issue: Yes ]
    readmissions required for study partipants


Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Impact Advanced Recovery®
3 briks daily (240 mL per brik) of Impact Advanced Recovery® to be take for 5 days before and after RC surgery
Dietary Supplement: Impact Advanced Recovery®
Placebo Comparator: Boost Plus®
3 briks daily (240 mL per brik) of Boost Plus® to be take for 5 days before and after RC surgery
Dietary Supplement: Boost Plus®

Detailed Description:

Radical cystectomy (RC) is the removal of the entire bladder and nearby organs that may contain cancer cells. It is a major surgery that can lead to breakdown of proteins in the body and a decreased immune response, both of which increase the risk of illness and death. Poor nutrition status before RC surgery is linked to a higher rate of death after surgery. Therefore, it is important to eat a balanced diet before and after RC surgery to avoid negative outcomes.

Studies show that patients who drink a nutritional supplement that may enhance the immune system before and after gastro-intestinal surgery may have fewer infections and shorter hospital stays after surgery. Patients with cancer of the colon/rectum, stomach, and pancreas who drank a similar immune-enhancing nutritional supplement before and after surgery also had fewer infections.

The purpose of this study is to attain pilot data for a larger trial.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men undergoing RC surgery for primary bladder cancer

Exclusion Criteria:

  • Patients with swallowing difficulties or unable to tolerate oral intake
  • Evidence of metastatic disease
  • Weight loss ≥ 10% (with respect to usual body weight) in the 6 months prior to surgery or BMI ≤ 18.5
  • Patients undergoing cystectomy for non-bladder primary malignancy or cancer type other than urothelial
  • Active viral infections such as Human immunodeficiency virus (HIV) positive, hepatitis, or who have a known immunodeficient state
  • Prior history of gouty arthritis or uric acid stones
  • Patients with milk, soy, or fish allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868087

Contacts
Contact: Jill Hamilton-Reeves, PhD, RD, LD (913) 588-7650 jhamilton-reeves@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Jill Hamilton-Reeves, PhD RD LD
American Cancer Society, Inc.
Nestle HealthCare Nutrition
Investigators
Principal Investigator: Jill Hamilton-Reeves, PhD, RD, LD University of Kansas
  More Information

No publications provided

Responsible Party: Jill Hamilton-Reeves, PhD RD LD, Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01868087     History of Changes
Other Study ID Numbers: 13730
Study First Received: May 29, 2013
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
nutritional supplement
immune system
RC surgery

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 20, 2014