HIIT Following Breast Cancer Chemotherapy

University of Florida

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: 12-week Observation Period; Behavioral: 12-week Intervention Period

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05913713

1R21AG078995-01A1 (U.S. NIH Grant/Contract)

IRB202300460 -N

Details and patient eligibility

About

Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.

Enrollment: 158 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients based on biological sex
• 18 to 85 years of age
• diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer
• completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation
• absence of contraindications to exercise or to participate in study
• study clinician approval

Exclusion criteria

• do not meet inclusion criteria
• scheduled to receive surgery or radiation therapy during the intervention period
• 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)
• lymphedema stage ≥2 prior to study enrollment
• are pregnant
• current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 3 patient groups

High Intensity Interval Training (HIIT)

Experimental group

Description:

Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.

Treatment:

Behavioral: 12-week Intervention Period

Behavioral: 12-week Observation Period

Moderate Intensity Continuous Training (MICT)

Experimental group

Description:

Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.

Treatment:

Behavioral: 12-week Intervention Period

Behavioral: 12-week Observation Period

Usual Care (UC)

Other group

Description:

Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise).

Treatment:

Behavioral: 12-week Intervention Period

Behavioral: 12-week Observation Period