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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01868087
Other study ID # 13730
Secondary ID
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


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
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