Clinical trial NCT02454777: High-Intensity Interval Training for Stage I-III Breast Cancer Patients
Official title: High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-05-27
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized pilot clinical trial studies the feasibility of high-intensity interval training in improving cardiovascular fitness in patients with stage I-III breast cancer undergoing chemotherapy with trastuzumab. Trastuzumab helps patients live longer, but may cause side effects to the heart. Aerobic exercise may help the heart function better, which may help protect it against side effects from trastuzumab. Exercise may also help reduce fatigue and prevent cancer from coming back. High-intensity interval training involves short bursts of higher intensity efforts with longer periods of recovery. This may also allow patients who cannot exercise for a long period of time to still be physically active. This trial studies whether patients can tolerate high-intensity interval training, and how well it works in improving fitness in patients with breast cancer receiving trastuzumab.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the feasibility (completion of \> 80% exercise sessions) of utilizing high-intensity interval training (HIT).

II. To determine the effects of HIT on aerobic exercise adaptation when compared to delayed group.

III. To examine the effects of HIT on left ventricular function when compared to delayed group.

IV. To determine the effects of HIT on endothelial function, arterial stiffness, and vascular atherosclerosis when compared to delayed group.

OUTLINE: Participants are randomized to 1 of 2 groups.

ARM I: HIT (High-intensity Interval Training) group - Participants undergo HIT over 30 minutes, thrice weekly for 8 weeks.

ARM II: DEL (Delayed/usual care) group - Participants maintain their current sedentary activity level (\< 60 minutes of total exercise per week) for 8 weeks. Participants document their weekly activity in an exercise log. Following completion of all study visits, participants are given the option to complete the HIT exercise program as in Arm I.

After completion of study, patients are followed up at weeks 9 and 17.

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* Diagnosed with early stage (I-III) breast cancer, without evidence of metastatic disease
* Planned (neo)adjuvant therapy with trastuzumab (Herceptin) and/or anthracycline-based chemotherapy
* Not currently pregnant or planning to become pregnant throughout the duration of cancer treatment
* Physician (oncologist) clearance to participate in exercise at moderate to high intensity
* Have read and signed study informed consent document (ICF)
* EXERCISE INCLUSION CRITERIA:
* Normal body temperature (=\< 100 degrees F)
* Resting blood pressure and/or heart rate within normal limits
* Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session

Exclusion Criteria:

* Advanced stage (stage IV) or metastatic breast cancer diagnosis (screening for metastases with scans only needed if there is clinical suspicion for metastases)
* Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
* Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc.)
* Moderate to highly active level of physical activity (e.g. currently participating in \>= 60 minutes of moderate aerobic activity weekly)
* Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
* EXERCISE EXCLUSION CRITERIA:
* Presence of fever (\>= 100 degrees F)
* Resting blood pressure and/or heart rate outside normal limits
* Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session

Primary outcomes:
measure: Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
timeFrame: Up to 17 weeks
Secondary outcomes:
measure: Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)
timeFrame: Baseline to up to week 17
measure: Change in left ventricular function
timeFrame: Baseline to up to week 17
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Christina Dieli-Conwright
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee K, Norris MK, Wang E, Dieli-Conwright CM. Effect of high-intensity interval training on patient-reported outcomes and physical function in women with breast cancer receiving anthracycline-based chemotherapy. Support Care Cancer. 2021 Nov;29(11):6863-6870. doi: 10.1007/s00520-021-06294-7. Epub 2021 May 20.
citation: Lee K, Kang I, Mack WJ, Mortimer J, Sattler F, Salem G, Dieli-Conwright CM. Feasibility of high intensity interval training in patients with breast Cancer undergoing anthracycline chemotherapy: a randomized pilot trial. BMC Cancer. 2019 Jul 3;19(1):653. doi: 10.1186/s12885-019-5887-7.
citation: Lee K, Kang I, Mack WJ, Mortimer J, Sattler F, Salem G, Lu J, Dieli-Conwright CM. Effects of high-intensity interval training on vascular endothelial function and vascular wall thickness in breast cancer patients receiving anthracycline-based chemotherapy: a randomized pilot study. Breast Cancer Res Treat. 2019 Sep;177(2):477-485. doi: 10.1007/s10549-019-05332-7. Epub 2019 Jun 24.
citation: Lee K, Kang I, Mortimer JE, Sattler F, Mack WJ, Fitzsimons LA, Salem G, Dieli-Conwright CM. Effects of high-intensity interval training on vascular function in breast cancer survivors undergoing anthracycline chemotherapy: design of a pilot study. BMJ Open. 2018 Jun 30;8(6):e022622. doi: 10.1136/bmjopen-2018-022622.