Surgery Clinical Trial
Official title:
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
Jill Hamilton-Reeves, PhD RD LD | American Cancer Society, Inc., Nestle HealthCare Nutrition |
United States,
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
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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