Endometrial Cancer Diet and Exercise

July 27, 2021 updated by: Duke University

Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors

This study will evaluate whether the use of the Jawbone wristband monitor, in connection with home-based exercise and nutritional counseling can be safely completed and improve cardiorespiratory fitness (heart and lung health) in women with early stage endometrial cancer who have undergone surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ages > 18 years.
  • Localized endometrial cancer (stage I and II); no evidence of stage III or IV disease.
  • At least 2 months was passed since the hysterectomy and enrollment.
  • Karnofsky performance status > 70%.
  • Body mass index of 30.0 - 49.9 and body weight < 300 pounds.
  • No plan for adjuvant endometrial cancer therapy.
  • Able to exercise safely on a treadmill.
  • No absolute contraindications to exercise testing as recommended by the American Thoracic Society. No recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
  • The subject is not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting.
  • Able to provide informed consent.
  • Have reliable transportation to the testing facilities.
  • Subjects must be able to speak and understand English to participate in this study.
  • Subjects must have a personal mobile device compatible for the activity monitor

Compatible devices for the activity monitors are below:

  • Android

    o Activity monitor is compatible with most Android devices equipped with Bluetooth 4.0 and running Android 4.3 (Jelly Bean) or later.

  • iOS

    • iPhone 4s (or newer)
    • iPod touch (5th generation or newer)
    • iPad (3rd generation or newer)
    • iPad mini (1st generation or newer)
    • iPad Air (1st generation or newer)

Exclusion Criteria:

-

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: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adult women with early stage localized endometrial cancer
Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
Behavioral: Home-based aerobic exercise and nutritional counseling
Moderate walking and running with nutritional counseling at study visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as measured by adherence to weekly walking sessions
Time Frame: Week 12
Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed
Week 12
Safety as measured by the type and prevalence of adverse events during study-related assessments
Time Frame: Week 12
Collection of events related to cardiopulmonary testing and self-reported events during off-site exercise training
Week 12
change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak
Time Frame: baseline and 12 weeks
baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure
Time Frame: baseline and 12 weeks
baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile
Time Frame: baseline and 12 weeks
baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein
Time Frame: baseline and 12 weeks
baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by body composition
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
patient experience with exercise and nutrition counseling as measured by telephone questionnaire
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

Duke Cancer Institute

Investigators

  • Principal Investigator: Angeles A Secord, M.D., Duke University

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 (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00074542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Early Stage Endometrial Cancer

Clinical Trials on Home-based aerobic exercise and nutritional counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe