Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study
Urinary Bladder Neoplasms
Dietary Supplement: Boost Plus®
Dietary Supplement: Impact Advanced Recovery®
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Impact Advanced Recovery® for Radical Cystectomy (RC) Patients|
- Immune and Inflammation Response [ Time Frame: Change from Baseline to Day 30 ] [ Designated as safety issue: Yes ]Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.
- preservation of body weight and fat free mass (FFM) [ Time Frame: Change from Baseline to 30 Days ] [ Designated as safety issue: No ]measure of body weight and fat free mass between groups over course of the study
- count of infections after surgery [ Time Frame: Change from Baseline to 30 Days ] [ Designated as safety issue: Yes ]count of total number of infections affecting study participants
- hospital readmission rate [ Time Frame: Change from Baseline to 30 Days ] [ Designated as safety issue: Yes ]readmissions required for study partipants
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: 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
|Dietary Supplement: Impact Advanced Recovery®|
Placebo Comparator: Boost Plus®
3 briks daily (240 mL per brik) of Boost Plus® to be take for 5 days before and after RC surgery
|Dietary Supplement: Boost Plus®|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868087
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Jill Hamilton-Reeves, PhD, RD, LD||University of Kansas Medical Center|