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

Surgery Clinical Trial

Official title:

Impact Advanced Recovery® for Radical Cystectomy (RC) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868087
• Other study ID #: 13730
• Status: Completed
• Phase: Phase 0
• First received: May 29, 2013
• Last updated: April 5, 2016
• Start date: July 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Radical Cystectomy
• Surgery
• Urinary Bladder Neoplasms

Intervention

Dietary Supplement:
• Boost Plus®

• Impact Advanced Recovery®

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Jill Hamilton-Reeves, PhD RD LD	American Cancer Society, Inc., Nestle HealthCare Nutrition

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune and Inflammation Response	Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.	Change from Baseline to Day 30	Yes
Secondary	preservation of body weight and fat free mass (FFM)	measure of body weight and fat free mass between groups over course of the study	Change from Baseline to 30 Days	No
Secondary	count of infections after surgery	count of total number of infections affecting study participants	Change from Baseline to 30 Days	Yes
Secondary	hospital readmission rate	readmissions required for study partipants	Change from Baseline to 30 Days	Yes