Endometrial Cancer Diet and Exercise

NCT02987881 | Completed

• 1 other identifier: Pro00074542
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Stage Endometrial Cancer

Outcome Measures

Primary Outcomes (7)

• 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

• 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

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

  baseline and 12 weeks

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

  baseline and 12 weeks

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

  baseline and 12 weeks

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

  baseline and 12 weeks

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

  baseline and 12 weeks

Secondary Outcomes (1)

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

  16 weeks

Study Arms (1)

Adult women with early stage localized endometrial cancer

EXPERIMENTAL

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

Behavioral: Home-based aerobic exercise and nutritional counseling

Interventions

Home-based aerobic exercise and nutritional counseling BEHAVIORAL

Moderate walking and running with nutritional counseling at study visits.

Adult women with early stage localized endometrial cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Duke Cancer Institute: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related 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;11:669961. doi: 10.3389/fonc.2021.669961. eCollection 2021.

  PMID: 34178654 RESULT

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Angeles A Secord, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: February 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 2, 2021

Record last verified: 2019-06

Locations

US (1)