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

Jill Hamilton-Reeves, PhD RD LD

Status and phase: Completed; Early Phase 1

Conditions: Bladder Cancer; Urinary Bladder Neoplasms; Surgery; Radical Cystectomy

Treatments: Dietary Supplement: Boost Plus®; Dietary Supplement: Impact Advanced Recovery®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01868087

13730

Details and patient eligibility

About

The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications.

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Impact Advanced Recovery®

Experimental group

Description:

3 briks daily (240 mL per brik) of Impact Advanced Recovery® to be take for 5 days before and after RC surgery

Treatment:

Dietary Supplement: Impact Advanced Recovery®

Boost Plus®

Placebo Comparator group

Description:

3 briks daily (240 mL per brik) of Boost Plus® to be take for 5 days before and after RC surgery

Treatment:

Dietary Supplement: Boost Plus®