NCT02454777

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

3.8 years

First QC Date

May 21, 2015

Last Update Submit

April 1, 2021

Conditions

Stage IA Breast CancerStage IB Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate

    The exercise program will be considered feasible if participants complete greater than 80% of exercise sessions. Participant attendance rates will be used to establish compliance and will be used to provide a perspective on how and to what extent cancer patients will participate in an experimental exercise intervention and what variations in exercise intensities may be tolerated. Feasibility will be assessed based on both program attendance as well as exercise time completed.

    Up to 17 weeks

Secondary Outcomes (2)

  • Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)

    Baseline to up to week 17

  • Change in left ventricular function

    Baseline to up to week 17

Study Arms (2)

ARM I (HIT group)

EXPERIMENTAL

Participants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks.

Behavioral: Exercise InterventionOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (Delayed group)

ACTIVE COMPARATOR

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 program as in Arm I.

Other: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Exercise InterventionBEHAVIORAL

Undergo HIT

ARM I (HIT group)
Laboratory Biomarker AnalysisOTHER

Correlative studies

ARM I (HIT group)Arm II (Delayed group)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
ARM I (HIT group)Arm II (Delayed group)
Questionnaire AdministrationOTHER

Ancillary studies

ARM I (HIT group)Arm II (Delayed group)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (4)

  • 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.

    PMID: 34018031DERIVED

  • 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.

    PMID: 31269914DERIVED

  • 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.

    PMID: 31236810DERIVED

  • 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.

    PMID: 29961039DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christina Dieli-Conwright

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 27, 2015

Study Start

September 29, 2015

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

April 5, 2021

Record last verified: 2021-04

Locations

US(1)