All-extremity Exercise During Breast Cancer Chemotherapy
NCT ID: NCT04914663
Last Updated: 2025-10-01
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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RECRUITING
NA
68 participants
INTERVENTIONAL
2024-04-05
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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All-extremity exercise
Exercise training
Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.
Treadmill exercise
Exercise training
Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.
Usual Care
No interventions assigned to this group
Interventions
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Exercise training
Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.
Eligibility Criteria
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Inclusion Criteria
* Female
* 18 to 85 years of age
* Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane)
* Absence of contraindications to exercise
* Study clinician approval
* Able to give consent
* Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process
* Receiving targeted therapies (CDK4/6 or PARP inhibitors)
* Receiving radiation therapy concurrent with chemotherapy
* Lymphedema stage ≥ 2 prior to study enrollment
* Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
* Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
18 Years
85 Years
FEMALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Demetra Christou, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Integrative Cardiovasculal Physiology Laboratory, University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRO00031309
Identifier Type: OTHER
Identifier Source: secondary_id
OCR40536
Identifier Type: OTHER
Identifier Source: secondary_id
IRB202100182 -N
Identifier Type: -
Identifier Source: org_study_id
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