Bladder Cancer Clinical Trial

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

Summary

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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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.

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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

Study is for people with:

Bladder Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT01868087

Recruitment Status:

Completed

Sponsor:

Jill Hamilton-Reeves, PhD RD LD

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There is 1 Location for this study

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University of Kansas Medical Center
Kansas City Kansas, 66160, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT01868087

Recruitment Status:

Completed

Sponsor:


Jill Hamilton-Reeves, PhD RD LD

How clear is this clinincal trial information?

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