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Behavioral Intervention

Weight Management for Prostate Cancer (WARRIOR Trial)

N/A

Waitlist Available

Led By Jill Hamilton-Reeves, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2)

Be older than 18 years old

Must not have

Undergoing salvage therapy

Castration-resistant PCa

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how a weight management program affects certain substances in the blood that can indicate the presence or severity of cancer, compared to just following a basic diet and exercise plan.

Who is the study for?

This trial is for men newly diagnosed with prostate cancer (stages T1 or T2) who are overweight or obese, with a BMI between 25-45 kg/m2. Participants must be scheduled for radical prostatectomy and have internet access to join the study.

What is being tested?

The study is examining the effects of a weight management program on cancer biomarkers in blood versus just receiving an educational flyer about diet and exercise. It aims to see if managing weight can influence recovery from surgery and cancer outcomes.

What are the potential side effects?

Since this trial involves non-invasive interventions like education and weight management programs, side effects may include typical reactions to lifestyle changes such as muscle soreness, fatigue, or dietary adjustment discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man newly diagnosed with prostate cancer and scheduled for complete prostate removal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving treatment after my cancer has not responded to initial treatments.

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My prostate cancer is not responding to hormone therapy.

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I have had radiation therapy for cancer.

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I have a serious health condition like kidney disease or uncontrolled diabetes.

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I am currently undergoing treatment for cancer.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Impact of weight loss before and weight maintenance after Prostate Cancer (PCa) surgery on immunosuppressive factors

Secondary study objectives

Change in Quality of Life

Change in body composition

Change in weight

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Weight Loss and Weight MaintenanceExperimental Treatment2 Interventions

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.

Group II: ControlActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Weight Loss Program

2006

N/A

~250

0 / 7Eligibility criteria met