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Endometrial Cancer Diet and Exercise

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Duke University

Status

Completed

Conditions

Early Stage Endometrial Cancer

Treatments

Behavioral: Home-based aerobic exercise and nutritional counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02987881
Pro00074542

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Adult women with early stage localized endometrial cancer
Experimental group
Description:
Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
Treatment:
Behavioral: Home-based aerobic exercise and nutritional counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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