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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Bladder Cancer Radical Cystectomy Urinary Bladder Neoplasms Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Impact Advanced Recovery®

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

Group Type EXPERIMENTAL

Impact Advanced Recovery®

Intervention Type DIETARY_SUPPLEMENT

Boost Plus®

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

Group Type PLACEBO_COMPARATOR

Boost Plus®

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Boost Plus®

Intervention Type DIETARY_SUPPLEMENT

Impact Advanced Recovery®

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No