Improving brain health in breast cancer patients through high-intensity exercise
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)
This study is testing if a 16-week high-intensity exercise program can help improve brain health and heart fitness in women undergoing chemotherapy for breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04724499 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effects of a 16-week high-intensity interval training (HIIT) program on cognitive function and cardiovascular health in women undergoing chemotherapy for breast cancer. Participants will be randomly assigned to either the HIIT group or a control group that performs home-based stretching exercises. The study aims to assess improvements in brain health, cardiac fitness, and overall quality of life through various evaluations, including MRI and fitness assessments. This pilot trial is the first of its kind to explore the impact of HIIT in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old, newly diagnosed with Stage I-III breast cancer, and scheduled to receive chemotherapy.
Not a fit: Patients with significant cardiovascular, respiratory, or musculoskeletal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function and cardiovascular health in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While this approach is novel in the context of breast cancer patients undergoing chemotherapy, previous studies have shown positive effects of exercise on cognitive function in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina Dieli-Conwright, MD — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, MD
- Email: ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.