NCT03261271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 26, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

6.1 years

First QC Date

August 22, 2017

Results QC Date

October 29, 2024

Last Update Submit

April 4, 2025

Conditions

ObesityProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 monocytic myeloid-derived suppressor cells (mMDSCs). The absolute number of cell counts were calculated using the lymphocyte count abstracted from the complete blood count with differential.

    Change from Baseline to Month 6

Secondary Outcomes (4)

  • Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors

    Change from Baseline to Month 6

  • Change in Weight

    Change from Baseline to Month 6

  • Change in Body Composition

    Change from Baseline to Study End

  • Change in Quality of Life

    Change from Baseline to Month 6

Study Arms (2)

Weight Loss and Weight Maintenance

EXPERIMENTAL

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.

Behavioral: Weight Loss ProgramBehavioral: Weight Maintenance Program

Control

ACTIVE COMPARATOR

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

Behavioral: Standardized educational flyer

Interventions

Weight Loss ProgramBEHAVIORAL

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

Weight Loss and Weight Maintenance
Standardized educational flyerBEHAVIORAL

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

Control
Weight Maintenance ProgramBEHAVIORAL

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

Weight Loss and Weight Maintenance

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

ObesityProstatic Neoplasms

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

This randomized controlled trial could not be blinded to participants due to the nature of the intervention.

Results Point of Contact

Title
Dr. Jill Hamilton-Reeves
Organization
University of Kansas Medical Center
jhamilton-reeves@kumc.edu
913-588-7650

Study Officials

  • Jill Hamilton-Reeves, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 24, 2017

Study Start

November 2, 2017

Primary Completion

November 28, 2023

Study Completion

March 25, 2025

Last Updated

April 13, 2025

Results First Posted

February 26, 2025

Record last verified: 2025-04

Locations

US(1)