Skip to main content
OpenTrials
Completed

NCT Number: NCT02252484

Energy Balance for Prostate Cancer Survivorship

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Body Weight Body Weight Changes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Weight Loss

Age range

50 year–72 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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:

  • Diet
  • Physical activity
  • Coaching
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Weight Loss Program

Other

Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.

Standard of care

Other

Standard of Care for this patient population.

Primary outcomes

  1. Change in body weight during the post-surgical period

    Time frame: Change from Surgery to Week 20

Secondary outcomes

  1. Changes in body weight during the pre-surgical weight-loss intervention

    Time frame: Change from Baseline to Week 8

  2. 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.

  3. Prostate cancer status

    Time frame: Week 20

    Evidence of recurrence of cancer

  4. 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.

Sponsors and collaborators

Lead sponsor

Jill Hamilton-Reeves, PhD RD LD

Other

Collaborators

  • University of Kansas Medical Center

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2014
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.