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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01868087
First Posted: June 4, 2013
Last Update Posted: April 7, 2016
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.
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
  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® Early Phase 1

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

Resource links provided by NLM:


Further study details as provided by Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • Immune and Inflammation Response [ Time Frame: Change from Baseline to Day 30 ]
    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 ]
    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 ]
    count of total number of infections affecting study participants

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


Enrollment: 30
Study Start Date: July 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes 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
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): NCT01868087


Locations
United States, Kansas
University of Kansas Medical Center
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 Medical Center
  More Information

Publications:
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
First Submitted: May 29, 2013
First Posted: June 4, 2013
Last Update Posted: April 7, 2016
Last Verified: April 2016

Keywords provided by Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center Research Institute:
nutritional supplement
immune system
RC surgery

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