Impact Advanced Recovery® for Radical Cystectomy (RC) Patients
40 Years
90 Years
Male
Bladder Cancer, Radical Cystectomy, Urinary Bladder Neoplasms, Surgery
Trial Information
Impact Advanced Recovery® for Radical Cystectomy (RC) Patients
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Immune and Inflammation Response
Outcome Description:
Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.
Outcome Time Frame:
Change from Baseline to Day 30
Safety Issue:
Yes
Principal Investigator
Jill Hamilton-Reeves, PhD, RD, LD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Kansas
Authority:
United States: Institutional Review Board
Study ID:
13730
NCT ID:
NCT01868087
Start Date:
July 2013
Completion Date:
September 2014
Related Keywords:
- Bladder Cancer
- Radical Cystectomy
- Urinary Bladder Neoplasms
- Surgery
- nutritional supplement
- immune system
- RC surgery
- Urinary Bladder Neoplasms
- Neoplasms
Name | Location |
|---|---|
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
