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

NCT ID: NCT03261271

Last Updated: 2025-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2025-03-25

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Weight Loss and Weight Maintenance

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 Type EXPERIMENTAL

Weight Loss Program

Intervention Type BEHAVIORAL

Program involves one-on-one coaching, diet meal plan, and physical activity plan.

Weight Maintenance Program

Intervention Type BEHAVIORAL

Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.

Control

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

Group Type ACTIVE_COMPARATOR

Standardized educational flyer

Intervention Type BEHAVIORAL

The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.

Interventions

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Weight Loss Program

Program involves one-on-one coaching, diet meal plan, and physical activity plan.

Intervention Type BEHAVIORAL

Standardized educational flyer

The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.

Intervention Type BEHAVIORAL

Weight Maintenance Program

Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jill Hamilton-Reeves, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RSG-17-050-01-NEC

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00141060

Identifier Type: -

Identifier Source: org_study_id

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