NCT04724499 Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy
| NCT ID | NCT04724499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-07-14 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2021-07-14 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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 & Investigator
Christina Dieli-Conwright, MD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT04724499 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04724499 currently recruiting?
Yes, NCT04724499 is actively recruiting participants. Contact the research team at ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU for enrollment information.
Where is the NCT04724499 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04724499 clinical trial?
NCT04724499 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Christina Dieli-Conwright, MD at Dana-Farber Cancer Institute. The trial plans to enroll 30 participants.
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