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Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy (WARRIOR)

Primary Purpose

Obesity, Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss Program
Standardized educational flyer
Weight Maintenance Program
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2)
  • Body Mass Index (BMI) 25-45 kg/m2
  • Has internet access

Exclusion Criteria:

  • History of 5 alpha reductase inhibitors prior 3 months
  • History of radiation therapy for cancer treatment
  • Taking active cancer treatment
  • Undergoing salvage therapy
  • Castration-resistant PCa
  • Evidence of metastasis
  • Evidence of biochemical recurrence
  • High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weight Loss and Weight Maintenance

Control

Arm Description

Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.

Participants will receive a standardized educational flyer about a healthy diet and exercise.

Outcomes

Primary Outcome Measures

Impact of weight loss before and weight maintenance after Prostate Cancer (PCa) surgery on immunosuppressive factors
Impact will be measured by changes in specific blood immune biomarker biomarkers.

Secondary Outcome Measures

Impact of weight loss before and weight maintenance after PCa surgery on inflammation factors
Impact will be measured by changes in specific blood inflammation biomarkers.
Change in weight
Change in body composition
Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA).
Change in Quality of Life
Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life.

Full Information

First Posted
August 22, 2017
Last Updated
September 1, 2020
Sponsor
University of Kansas Medical Center
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03261271
Brief Title
Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
Acronym
WARRIOR
Official Title
Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight Loss and Weight Maintenance
Arm Type
Experimental
Arm Description
Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will receive a standardized educational flyer about a healthy diet and exercise.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Program
Intervention Description
Program involves one-on-one coaching, diet meal plan, and physical activity plan.
Intervention Type
Behavioral
Intervention Name(s)
Standardized educational flyer
Intervention Description
The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.
Intervention Type
Behavioral
Intervention Name(s)
Weight Maintenance Program
Intervention Description
Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.
Primary Outcome Measure Information:
Title
Impact of weight loss before and weight maintenance after Prostate Cancer (PCa) surgery on immunosuppressive factors
Description
Impact will be measured by changes in specific blood immune biomarker biomarkers.
Time Frame
Change from Baseline to Month 6
Secondary Outcome Measure Information:
Title
Impact of weight loss before and weight maintenance after PCa surgery on inflammation factors
Description
Impact will be measured by changes in specific blood inflammation biomarkers.
Time Frame
Change from Baseline to Month 6
Title
Change in weight
Time Frame
Change from Baseline to Month 6
Title
Change in body composition
Description
Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA).
Time Frame
Change from Baseline to Prior to Surgery, from 4 to 16 weeks
Title
Change in Quality of Life
Description
Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life.
Time Frame
Change from Baseline to Month 6

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2) Body Mass Index (BMI) 25-45 kg/m2 Has internet access Exclusion Criteria: History of 5 alpha reductase inhibitors prior 3 months History of radiation therapy for cancer treatment Taking active cancer treatment Undergoing salvage therapy Castration-resistant PCa Evidence of metastasis Evidence of biochemical recurrence High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Hamilton-Reeves, PhD
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

Learn more about this trial

Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy

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