Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01868087|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : April 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Radical Cystectomy Urinary Bladder Neoplasms Surgery||Dietary Supplement: Boost Plus® Dietary Supplement: Impact Advanced Recovery®||Early Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact Advanced Recovery® for Radical Cystectomy (RC) Patients|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
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®
- Immune and Inflammation Response [ Time Frame: Change from Baseline to Day 30 ]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 ]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 ]count of total number of infections affecting study participants
- hospital readmission rate [ Time Frame: Change from Baseline to 30 Days ]readmissions required for study partipants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|