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Completed

NCT Number: NCT02987881

Endometrial Cancer Diet and Exercise

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

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

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

-

Treatment and study plan

Home-based aerobic exercise and nutritional counseling

Behavioral

Moderate walking and running with nutritional counseling at study visits.

Primary outcomes

  1. 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

  2. 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

  3. change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak

    Time frame: baseline and 12 weeks

  4. change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure

    Time frame: baseline and 12 weeks

  5. change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile

    Time frame: baseline and 12 weeks

  6. change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein

    Time frame: baseline and 12 weeks

  7. change in cardiorespiratory fitness and CVD risk profile as measured by body composition

    Time frame: baseline and 12 weeks

Secondary outcomes

  1. patient experience with exercise and nutrition counseling as measured by telephone questionnaire

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Duke Cancer Institute

Registry information

Official study title

Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 9, 2016
Registry last updated
Aug 2, 2021

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.

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