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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 19, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 19, 2014
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 July 20, 2014