Status:
RECRUITING
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
American Institute for Cancer Research
Conditions:
Breast Cancer
Chemotherapy Effect
Eligibility:
FEMALE
18+ years
Phase:
NA
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 c...
Detailed Description
This research study is a randomized controlled pilot trial that will compare an exercise group to a control group on brain health, cardiac fitness and overall quality of life in breast cancer patients...
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.
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04724499
Start Date
July 14 2021
End Date
June 15 2026
Last Update
January 27 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115