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

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ClinicalTrials.gov Identifier: NCT01868087
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : April 7, 2016
Sponsor:
Collaborators:
American Cancer Society, Inc.
Nestlé
Information provided by (Responsible Party):
Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE June 4, 2013
Last Update Posted Date April 7, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01868087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study
Official Title  ICMJE Impact Advanced Recovery® for Radical Cystectomy (RC) Patients
Brief Summary The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Radical Cystectomy
  • Urinary Bladder Neoplasms
  • Surgery
Intervention  ICMJE
  • Dietary Supplement: Boost Plus®
  • Dietary Supplement: Impact Advanced Recovery®
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Dietary Supplement: Boost Plus®
Publications * Hamilton-Reeves JM, Bechtel MD, Hand LK, Schleper A, Yankee TM, Chalise P, Lee EK, Mirza M, Wyre H, Griffin J, Holzbeierlein JM. Effects of Immunonutrition for Cystectomy on Immune Response and Infection Rates: A Pilot Randomized Controlled Clinical Trial. Eur Urol. 2016 Mar;69(3):389-92. doi: 10.1016/j.eururo.2015.11.019. Epub 2015 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2013)
60
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01868087
Other Study ID Numbers  ICMJE 13730
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center
Study Sponsor  ICMJE Jill Hamilton-Reeves, PhD RD LD
Collaborators  ICMJE
  • American Cancer Society, Inc.
  • Nestlé
Investigators  ICMJE
Principal Investigator: Jill Hamilton-Reeves, PhD, RD, LD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP