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Improving Cognitive Function with Exercise in Breast Cancer Patients Undergoing Chemotherapy

This study is looking at whether a 16-week exercise program called High-Intensity Interval Training (HIIT) can help improve brain health and heart function in women with newly diagnosed breast cancer (Stage I-III) who are undergoing chemotherapy. You would be randomly assigned to either the HIIT group or a stretching program. The researchers want to see if HIIT can improve thinking skills like executive function (planning and decision-making) and attention, which will be measured at 16 weeks. This is a pilot study, meaning it's the first time this specific exercise is being tested in this setting. The study aims to enroll 30 women aged 18 and older.

Study design
This is a randomized controlled pilot study with 30 participants, comparing a High-Intensity Interval Training (HIIT) group to a stretching group.
What's involved
You would undergo screening, then participate in either a 16-week HIIT program or a 16-week stretching program. Procedures include MRI, blood tests, bone scans, fitness and strength assessments, and surveys at the start and follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
Your executive function and attention will be measured at 16 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04724499

Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy

Active, Not Recruiting
NAAges 18+InterventionalSupportive care
Dana-Farber Cancer Institute
~30 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:High-Intensity Intervals TrainingAttention Control

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Executive Function and Attention
Measured over 16 weeks
+5 more outcomes measured

Conditions

Breast Cancer
Chemotherapy Effect
Exercise Therapy
Cognitive Change

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Christina Dieli-Conwright, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Executive Function and Attention16 weeks

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

  • Executive Function-Global Cognition16 weeks

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

  • Executive Function-Working Memory16 weeks

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

  • Executive Function-Episodic Memory16 weeks

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

  • Executive Function-Semantic Fluency16 weeks

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

  • Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity16 weeks

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