search
Back to results

Endometrial Cancer Diet and Exercise

Primary Purpose

Early Stage Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based aerobic exercise and nutritional counseling
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Early Stage Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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:

-

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adult women with early stage localized endometrial cancer

Arm Description

Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2016
Last Updated
July 27, 2021
Sponsor
Duke University
Collaborators
Duke Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02987881
Brief Title
Endometrial Cancer Diet and Exercise
Official Title
Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Duke Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Endometrial Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult women with early stage localized endometrial cancer
Arm Type
Experimental
Arm Description
Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
Intervention Type
Behavioral
Intervention Name(s)
Home-based aerobic exercise and nutritional counseling
Intervention Description
Moderate walking and running with nutritional counseling at study visits.
Primary Outcome Measure Information:
Title
Feasibility as measured by adherence to weekly walking sessions
Description
Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed
Time Frame
Week 12
Title
Safety as measured by the type and prevalence of adverse events during study-related assessments
Description
Collection of events related to cardiopulmonary testing and self-reported events during off-site exercise training
Time Frame
Week 12
Title
change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak
Time Frame
baseline and 12 weeks
Title
change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure
Time Frame
baseline and 12 weeks
Title
change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile
Time Frame
baseline and 12 weeks
Title
change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein
Time Frame
baseline and 12 weeks
Title
change in cardiorespiratory fitness and CVD risk profile as measured by body composition
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
patient experience with exercise and nutrition counseling as measured by telephone questionnaire
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeles A Secord, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34178654
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.
Results Reference
result

Learn more about this trial

Endometrial Cancer Diet and Exercise

We'll reach out to this number within 24 hrs