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Impact Advanced Recovery® for Radical Cystectomy (RC) Patients

Phase 0
40 Years
90 Years
Not Enrolling
Bladder Cancer, Radical Cystectomy, Urinary Bladder Neoplasms, Surgery

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Trial Information

Impact Advanced Recovery® for Radical Cystectomy (RC) Patients

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Immune and Inflammation Response

Outcome Description:

Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.

Outcome Time Frame:

Change from Baseline to Day 30

Safety Issue:


Principal Investigator

Jill Hamilton-Reeves, PhD, RD, LD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Institutional Review Board

Study ID:




Start Date:

July 2013

Completion Date:

September 2014

Related Keywords:

  • Bladder Cancer
  • Radical Cystectomy
  • Urinary Bladder Neoplasms
  • Surgery
  • nutritional supplement
  • immune system
  • RC surgery
  • Urinary Bladder Neoplasms
  • Neoplasms



University of Kansas Medical Center Kansas City, Kansas  66160-7353