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

Primary Purpose

Bladder Cancer, Radical Cystectomy, Urinary Bladder Neoplasms

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Boost Plus®

Impact Advanced Recovery®

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring nutritional supplement, immune system, RC surgery

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Impact Advanced Recovery®

Boost Plus®

Arm Description

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

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

Outcomes

Primary Outcome Measures

Immune and Inflammation Response

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

Secondary Outcome Measures

preservation of body weight and fat free mass (FFM)

measure of body weight and fat free mass between groups over course of the study

count of infections after surgery

count of total number of infections affecting study participants

hospital readmission rate

readmissions required for study partipants

Full Information

NCT ID

NCT01868087

First Posted

May 29, 2013

Last Updated

April 5, 2016

Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

American Cancer Society, Inc., Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT01868087

Brief Title

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

Official Title

Impact Advanced Recovery® for Radical Cystectomy (RC) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

American Cancer Society, Inc., Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer, Radical Cystectomy, Urinary Bladder Neoplasms, Surgery

Keywords

nutritional supplement, immune system, RC surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Impact Advanced Recovery®

Arm Type

Experimental

Arm Description

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

Arm Title

Boost Plus®

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Boost Plus®

Intervention Type

Dietary Supplement

Intervention Name(s)

Impact Advanced Recovery®

Primary Outcome Measure Information:

Title

Immune and Inflammation Response

Description

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

Time Frame

Change from Baseline to Day 30

Secondary Outcome Measure Information:

Title

preservation of body weight and fat free mass (FFM)

Description

measure of body weight and fat free mass between groups over course of the study

Time Frame

Change from Baseline to 30 Days

Title

count of infections after surgery

Description

count of total number of infections affecting study participants

Time Frame

Change from Baseline to 30 Days

Title

hospital readmission rate

Description

readmissions required for study partipants

Time Frame

Change from Baseline to 30 Days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jill Hamilton-Reeves, PhD, RD, LD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26654125

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.

Results Reference

result

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

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