Energy Balance for Prostate Cancer Survivorship

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Standard of Care; Other: Weight Loss Program

• Registration Number: NCT02252484
• Lead Sponsor: Jill Hamilton-Reeves, PhD RD LD

Brief Summary

The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.

Detailed Description

The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:

1. Diet

2. Physical activity

3. Coaching

4. Diet and exercise monitoring tool

The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.

Study Timeline

• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Study Start: 2014-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)
• Body Mass Index (BMI) 25-45 kg/m2
• Have internet access
• Have an iPad/iPhone/iDevice

Exclusion Criteria

• History of 5 alpha reductase inhibitors prior 3 months
• History of radiation therapy
• Taking active cancer treatment
• Undergoing salvage therapy
• Castration-resistant prostate cancer
• Evidence of metastasis
• Evidence of biochemical recurrence
• High risk medical condition (e.g. gout or kidney disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison Group	Standard of Care	All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.
Weight loss intervention Group	Weight Loss Program	Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.

Primary Outcome Measures

Name	Time	Method
Change in body weight during the post-surgical period	Change from Surgery to Week 20

Secondary Outcome Measures

Name	Time	Method
Prostate cancer status	Week 20	Evidence of recurrence of cancer
Changes in body weight during the pre-surgical weight-loss intervention	Change from Baseline to Week 8
Changes in diet quality during the pre-surgical weight-loss intervention	Change from Baseline to Week 8	Changes will be measured by analyzing results from alternative healthy eating index scores.
Change in cardiovascular biomarkers	Change from Baseline to Week 20	Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States