Clinical trial NCT02987881: Endometrial Cancer Diet and Exercise
Official title: Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Stage Endometrial Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Cancer Institute
First posted: 2016-12-09
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Feasibility as measured by adherence to weekly walking sessions
timeFrame: Week 12
measure: Safety as measured by the type and prevalence of adverse events during study-related assessments
timeFrame: Week 12
measure: change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak
timeFrame: baseline and 12 weeks
measure: change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure
timeFrame: baseline and 12 weeks
measure: change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile
timeFrame: baseline and 12 weeks
measure: change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein
timeFrame: baseline and 12 weeks
measure: change in cardiorespiratory fitness and CVD risk profile as measured by body composition
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: patient experience with exercise and nutrition counseling as measured by telephone questionnaire
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Angeles A Secord, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz AR, Bartlett DB, Johnson JL, Broadwater G, Channell M, Nolte KC, Wilkes PA, Huffman KM, Secord AA. A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Front Oncol. 2021 Jun 11;11:669961. doi: 10.3389/fonc.2021.669961. eCollection 2021.