Clinical trial NCT01868087: Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study
Official title: Impact Advanced Recovery® for Radical Cystectomy (RC) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Bladder Cancer
Radical Cystectomy
Urinary Bladder Neoplasms
Surgery
Keywords: nutritional supplement
immune system
RC surgery
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Société des Produits Nestlé (SPN)
First posted: 2013-06-04
Enrollment: 30
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Immune and Inflammation Response
timeFrame: Change from Baseline to Day 30
Secondary outcomes:
measure: preservation of body weight and fat free mass (FFM)
timeFrame: Change from Baseline to 30 Days
measure: count of infections after surgery
timeFrame: Change from Baseline to 30 Days
measure: hospital readmission rate
timeFrame: Change from Baseline to 30 Days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jill Hamilton-Reeves, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamilton-Reeves JM, Bechtel MD, Hand LK, Schleper A, Yankee TM, Chalise P, Lee EK, Mirza M, Wyre H, Griffin J, Holzbeierlein JM. Effects of Immunonutrition for Cystectomy on Immune Response and Infection Rates: A Pilot Randomized Controlled Clinical Trial. Eur Urol. 2016 Mar;69(3):389-92. doi: 10.1016/j.eururo.2015.11.019. Epub 2015 Nov 30.