Endometrial Cancer Diet and Exercise

Early Stage Endometrial Cancer Clinical Trial

Official title:

Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987881
• Other study ID #: Pro00074542
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Early Stage Endometrial Cancer
• Endometrial Neoplasms

Intervention

Behavioral:
• Home-based aerobic exercise and nutritional counseling
Moderate walking and running with nutritional counseling at study visits.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 12
Primary	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	Week 12
Primary	change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak		baseline and 12 weeks
Primary	change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure		baseline and 12 weeks
Primary	change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile		baseline and 12 weeks
Primary	change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein		baseline and 12 weeks
Primary	change in cardiorespiratory fitness and CVD risk profile as measured by body composition		baseline and 12 weeks
Secondary	patient experience with exercise and nutrition counseling as measured by telephone questionnaire		16 weeks