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

University of Kansas Medical Center40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity Prostate Cancer

Interventions

Weight Loss ProgramBEHAVIORAL

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

Standardized educational flyerBEHAVIORAL

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

Weight Maintenance ProgramBEHAVIORAL

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

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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.)

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: Change from Baseline to Month 6

Secondary Outcomes

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

Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio.

Time frame: Change from Baseline to Month 6

Change in Weight

Body weight will be measured at participant study visits.

Time frame: Change from Baseline to Month 6

Change in Body Composition

Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA). Change in percent body fat will be analyzed between groups from baseline to study end.

Time frame: Change from Baseline to Study End

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.

Time frame: Change from Baseline to Month 6

Data from ClinicalTrials.gov

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