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

Early Phase 1

Completed

• Conditions: Radical Cystectomy; Urinary Bladder Neoplasms; Surgery; Bladder Cancer
• Interventions: Dietary Supplement: Boost Plus®; Dietary Supplement: Impact Advanced Recovery®

• Registration Number: NCT01868087
• Lead Sponsor: Jill Hamilton-Reeves, PhD RD LD

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 Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-04
• Study Start: 2013-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boost Plus®	Boost Plus®	3 briks daily (240 mL per brik) of Boost Plus® to be take for 5 days before and after RC surgery
Impact Advanced Recovery®	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

Primary Outcome Measures

Name	Time	Method
Immune and Inflammation Response	Change from Baseline to Day 30	Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.

Secondary Outcome Measures

Name	Time	Method
preservation of body weight and fat free mass (FFM)	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	Change from Baseline to 30 Days	count of total number of infections affecting study participants
hospital readmission rate	Change from Baseline to 30 Days	readmissions required for study partipants

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States