Endometrial Cancer Diet and Exercise

NCT ID: NCT02987881

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Early Stage Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Open Label

Study Groups

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Adult women with early stage localized endometrial cancer

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

Group Type EXPERIMENTAL

Home-based aerobic exercise and nutritional counseling

Intervention Type BEHAVIORAL

Moderate walking and running with nutritional counseling at study visits.

Interventions

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Home-based aerobic exercise and nutritional counseling

Moderate walking and running with nutritional counseling at study visits.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke Cancer Institute

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angeles A Secord, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 34178654 (View on PubMed)

Other Identifiers

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Pro00074542

Identifier Type: -

Identifier Source: org_study_id

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