An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients
NCT ID: NCT02878980
Last Updated: 2018-06-15
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2016-09-02
2018-12-31
Brief Summary
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Detailed Description
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I. To assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian cancer patients who have undergone debulking surgery and will be starting platinum-based chemotherapy, to an exercise trial.
II. To evaluate adherence to the data collection and exercise trial protocol. It is necessary to determine the feasibility of collecting tablet-based questionnaire data and blood samples at multiple time points in one visit. It is also critical to determine whether the exercise intervention is feasible in this patient population.
SECONDARY OBJECTIVES:
I. To examine changes in DNA repair function before and after a single exercise session.
II. To examine changes in DNA repair function, body composition, quality of life, symptoms and patient satisfaction with care over the treatment time course.
III. To examine the effect of the exercise intervention on these measurements.
IV. To follow the patients an additional 12-months for clinical outcomes defined as death, cancer recurrence, or new primary cancer.
OUTLINE: Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
After completion of study, patients are followed up for 12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (exercise intervention)
Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
Exercise Intervention
Undergo supervised 1-on-1 exercise sessions
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Exercise Intervention
Undergo supervised 1-on-1 exercise sessions
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
* Newly diagnosed, primary, epithelial ovarian cancer
* Have undergone surgical debulking
* Will be treated according to the Armstrong method
* Read and understand English
* All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jessica Clague DeHart, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2016-01183
Identifier Type: REGISTRY
Identifier Source: secondary_id
15388
Identifier Type: OTHER
Identifier Source: secondary_id
15388
Identifier Type: -
Identifier Source: org_study_id
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