All-extremity Exercise During Breast Cancer Chemotherapy

NCT ID: NCT04914663

Last Updated: 2025-10-01

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

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-05

Study Completion Date

2027-01-31

Brief Summary

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Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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All-extremity exercise

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.

Treadmill exercise

Group Type ACTIVE_COMPARATOR

Exercise training

Intervention Type BEHAVIORAL

Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.

Usual Care

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Demetra Christou, PhD

Role: CONTACT

3522941746

Eileen Handberg

Role: CONTACT

352-273-9082

Facility Contacts

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Demetra Christou, PhD

Role: primary

352-294-1746

Other Identifiers

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1R21HL152264-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

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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