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

Early Phase 1CompletedNCT01868087

Jill Hamilton-Reeves, PhD RD LD30 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bladder Cancer Radical Cystectomy Urinary Bladder Neoplasms Surgery

Interventions

Boost Plus®DIETARY_SUPPLEMENT

Impact Advanced Recovery®DIETARY_SUPPLEMENT

Eligibility

Sex: MALEMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Immune and Inflammation Response

Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.

Time frame: Change from Baseline to Day 30

Secondary Outcomes

preservation of body weight and fat free mass (FFM)

measure of body weight and fat free mass between groups over course of the study

Time frame: Change from Baseline to 30 Days

count of infections after surgery

count of total number of infections affecting study participants

Time frame: Change from Baseline to 30 Days

hospital readmission rate

readmissions required for study partipants

Time frame: Change from Baseline to 30 Days

Data from ClinicalTrials.gov

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