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

Obesity Clinical Trial

— WARRIOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03261271
• Other study ID #: STUDY00141060
• Secondary ID: RSG-17-050-01-NE
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 28, 2025
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Obesity
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Weight Loss Program
Program involves one-on-one coaching, diet meal plan, and physical activity plan.
• Standardized educational flyer
The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.
• Weight Maintenance Program
Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline to Month 6
Secondary	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 from Baseline to Month 6
Secondary	Change in weight		Change from Baseline to Month 6
Secondary	Change in body composition	Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA).	Change from Baseline to Prior to Surgery, from 4 to 16 weeks
Secondary	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.	Change from Baseline to Month 6