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

April 10, 2026 updated by: Jill Hamilton-Reeves, PhD RD LD

Impact Advanced Recovery® for Radical Cystectomy (RC) Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline to 30 Days
count of infections after surgery
Time Frame: Change from Baseline to 30 Days
count of total number of infections affecting study participants
Change from Baseline to 30 Days
hospital readmission rate
Time Frame: Change from Baseline to 30 Days
readmissions required for study partipants
Change from Baseline to 30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

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

Investigators

  • Principal Investigator: Jill Hamilton-Reeves, PhD, RD, LD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimated)

June 4, 2013

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Bladder Neoplasms

Clinical Trials on Impact Advanced Recovery®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe