NCT04724499

Brief Summary

The purpose of this research is to determine whether a 16-week high intensity interval training (HIIT) exercise program will improve brain health among women undergoing chemotherapy and also improve cardiovascular (heart) function. The names of the study interventions involved in this study are/is:

  • High-Intensity Interval Training (HIIT)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
10mo left

Started Jul 2021

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress86%
Jul 2021Apr 2027

First Submitted

Initial submission to the registry

January 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

January 19, 2021

Last Update Submit

January 20, 2026

Conditions

Exercise TherapyCognitive ChangeBreast CancerChemotherapy Effect

Keywords

Breast CancerChemotherapy EffectExercise TherapyCognitive Change

Outcome Measures

Primary Outcomes (6)

  • Executive Function and Attention

    Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.

    16 weeks

  • Executive Function-Global Cognition

    Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.

    16 weeks

  • Executive Function-Working Memory

    Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test

    16 weeks

  • Executive Function-Episodic Memory

    Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test

    16 weeks

  • Executive Function-Semantic Fluency

    Assess semantic fluency of High-Intensity Interval Training (HIIT) to attention controls participants using the category fluency test

    16 weeks

  • Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity

    Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)

    16 weeks

Secondary Outcomes (2)

  • Cardio Fitness-maximal aerobic capacity

    16 weeks

  • Cardio Fitness-maximal power output

    16 weeks

Study Arms (2)

High-Intensity Intervals Training

EXPERIMENTAL

Participants will be randomized into one of two groups: High-Intensity Intervals Training (HIIT) or Attention Control Participants assigned to the exercise group (HIIT), will receive an exercise bike and have 3 weekly supervised exercise training sessions for four (4) months/16weeks. Participants can choose to participate in the exercise sessions at home via zoom or in clinic. Participants will have two (2) baseline tests, one (1) midpoint test, two (2) post High-Intensity Intervals Training (HIIT) tests and four (4) month follow up test and receive 3 MRIs over the span of 9 months.

Behavioral: High-Intensity Intervals Training

Attention Control

ACTIVE COMPARATOR

Participants will be randomized into one of two groups: High-Intensity Intervals Training (HIIT) or Attention Control Participants assigned to the Attention Control group, will receive instruction on a 16 week home-based stretching program. Participants will have two (2) baseline tests, one (1) midpoint test, two (2) post home-based stretching program tests and receive 3 MRIs over the span of 9 months. At the end of the 16-week home-based stretching program, participants will be provided the option to participate in the High-Intensity Intervals Training (HIIT) program.

Other: Attention Control

Interventions

High-Intensity Intervals TrainingBEHAVIORAL

16 week exercise program with stationary bike.

High-Intensity Intervals Training
Attention ControlOTHER

16 week stretching program.

Attention Control

Eligibility Criteria

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

You may qualify if:

  • Written informed consent prior to any study-related procedures
  • Women newly diagnosed (Stage I-III) breast cancer.
  • Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
  • The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
  • Will receive (neo)adjuvant chemotherapy
  • Speak English
  • Able to provide physician clearance to participate in the exercise program
  • Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
  • Have not experienced a weight reduction ≥10% within the past 6 months
  • Currently participate in less than 60 minutes of structured exercise/week
  • Does not smoke (no smoking during previous 12 months)
  • Willing to travel to DFCI for assessments (54 visits total for those who elect the exercise group with on campus training session, 6 visits for those that elect the exercise at home option, 6 visits for those assigned to the control group)
  • Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
  • Patients with other active malignancies are ineligible for this study.
  • Patients with metastatic disease
  • Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
  • Participates in more than 60 minutes of structured exercise/week
  • Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
  • Have a pacemaker or any implantable device that are not MRI safe; the BWH/DFCI Standard MRI screening form
  • Is unable to travel to DFCI
  • Patients who are pregnant
  • Patients with claustrophobia
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

  • Wilson R, Kang DW, Tahbaz M, Norris M, Uno H, Ligibel J, Guenette J, Christopher C, Dieli-Conwright C. Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 7;12:e39740. doi: 10.2196/39740.

    PMID: 37027186DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christina Dieli-Conwright, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, MD

CONTACT

617-582-8321ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU

Mary Norris, MS

CONTACT

857-215-0195maryk_norris@dfci.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 26, 2021

Study Start

July 14, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US(1)