All-extremity Exercise During Breast Cancer Chemotherapy

University of Florida

Status

Enrolling

Conditions

Breast Cancer

Treatments

Behavioral: Exercise training

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04914663

PRO00031309 (Other Identifier)

1R21HL152264-01A1 (U.S. NIH Grant/Contract)

OCR40536 (Other Identifier)

IRB202100182 -N

Details and patient eligibility

About

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.

Enrollment

68 estimated patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

Do not meet inclusion criteria
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)