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OpenTrials
Completed

NCT Number: NCT01868087

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

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

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Key information

Age range

40 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Boost Plus®

Dietary Supplement

Impact Advanced Recovery®

Dietary Supplement

Primary outcomes

  1. 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 outcomes

  1. 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

  2. count of infections after surgery

    Time frame: Change from Baseline to 30 Days

    count of total number of infections affecting study participants

  3. hospital readmission rate

    Time frame: Change from Baseline to 30 Days

    readmissions required for study partipants

Sponsors and collaborators

Lead sponsor

Jill Hamilton-Reeves, PhD RD LD

Other

Collaborators

  • American Cancer Society, Inc.
  • Société des Produits Nestlé (SPN)

Registry information

Official study title

Impact Advanced Recovery® for Radical Cystectomy (RC) Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2013
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.