Bladder Cancer, Radical Cystectomy, Surgery, Urinary Bladder Neoplasms
Conditions
Keywords
nutritional supplement, immune system, RC surgery
Brief summary
The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTBoost Plus®
DIETARY_SUPPLEMENTImpact Advanced Recovery®
Sponsors
Jill Hamilton-Reeves, PhD RD LD
American Cancer Society, Inc.
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune and Inflammation Response | Change from Baseline to Day 30 | Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| preservation of body weight and fat free mass (FFM) | 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 | Change from Baseline to 30 Days | count of total number of infections affecting study participants |
| hospital readmission rate | Change from Baseline to 30 Days | readmissions required for study partipants |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJill Hamilton-Reeves, PhD, RD, LD
University of Kansas Medical Center
Outcome results
None listed