Energy Balance for Prostate Cancer Survivorship

September 6, 2016 updated by: Jill Hamilton-Reeves, PhD RD LD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weight loss intervention Group
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.
Other: Weight Loss Program
Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.
Active Comparator: Comparison Group
All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.
Other: Standard of Care
Standard of Care for this patient population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight during the post-surgical period
Time Frame: Change from Surgery to Week 20
Change from Surgery to Week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body weight during the pre-surgical weight-loss intervention
Time Frame: Change from Baseline to Week 8
Change from Baseline to Week 8
Changes in diet quality during the pre-surgical weight-loss intervention
Time Frame: Change from Baseline to Week 8
Changes will be measured by analyzing results from alternative healthy eating index scores.
Change from Baseline to Week 8
Prostate cancer status
Time Frame: Week 20
Evidence of recurrence of cancer
Week 20
Change in cardiovascular biomarkers
Time Frame: 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.
Change from Baseline to Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

University of Kansas Medical Center

Investigators

  • Principal Investigator: Jill Hamilton-Reeves, PhD, RD, LD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001274

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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