Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study

Study Overview
=================
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.

Official Title
-----------------
Impact Advanced Recovery® for Radical Cystectomy (RC) Patients

Conditions
-----------------
Bladder Cancer, Radical Cystectomy, Urinary Bladder Neoplasms, Surgery

Intervention / Treatment
-----------------
* Dietary Supplement: Boost Plus®
* Dietary Supplement: Impact Advanced Recovery®


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impact Advanced Recovery®<br>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®<br> <br> |
| Placebo Comparator: Boost Plus®<br>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®<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune and Inflammation Response | Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response. | Change from Baseline to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| count of infections after surgery | count of total number of infections affecting study participants | Change from Baseline to 30 Days | 
| hospital readmission rate | readmissions required for study partipants | Change from Baseline to 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutritional supplement, immune system, RC surgery