Clinical trial · Interventional
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)
NCT04724499CI-TRIAL-00125546CLARITYactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Cognitive Change | — | UNRESOLVED | — |
| Exercise Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control | Other | — | UNRESOLVED |
| High-Intensity Intervals Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-Intensity Intervals Training
- description
- 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.
- interventionNames
- Behavioral: High-Intensity Intervals Training
- type
- ACTIVE_COMPARATOR
- label
- Attention Control
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWilson 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 37027186