Breast CancerCLARITYNCT04724499
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy
A study testing High-Intensity Intervals Training in people with Breast Cancer and Chemotherapy Effect, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy Effect, Exercise Therapy
- What is being tested?
- High-Intensity Intervals Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)
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)
Read the 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 starting chemotherapy either before (pre-operative or neoadjuvant) or after surgery (post-operative or adjuvant)
This research study is a Pilot Study, which is the first-time investigators are examining this intervention in this setting. The study is trying to determine whether participating in a specific exercise program can improve brain and heart function, as there is some evidence that there can be cognitive changes after chemotherapy among some patients with breast cancer. This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for breast cancer.
Participants will be randomly assigned to one of two groups:
- Group A: High Intensity Interval Training (HIIT) for 16 weeks
- Group B: Attention Control for 16 weeks home-based stretching; the HIIT intervention will be available after the study ends
The research study procedures include screening for eligibility and study treatment including extensive evaluations of your fitness and brain health, including MRI, blood tests, bone scans, fitness and strength assessments, and surveys at study entry and follow up visits.
Participants will receive study treatment for 4 months and will be followed for 4 months.
The total time for participation in this study will be about 8 months.
It is expected that about 30 people will take part in this research study.
The American Institute for Cancer Research is supporting this research by providing funding for the study.
- Conditions
- Breast Cancer, Chemotherapy Effect, Exercise Therapy, Cognitive Change
- Being tested
- High-Intensity Intervals Training, Attention Control
- Keywords
- Breast Cancer, Chemotherapy Effect, Exercise Therapy, Cognitive Change
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Intervals TrainingBehavioural
16 week exercise program with stationary bike.
Attention ControlOther
16 week stretching program.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Intervals Training | Experimental | 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. Receives: Behavioral: High-Intensity Intervals Training |
| Attention Control | Active comparator | 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. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function and Attention
Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.
Measured: 16 weeks
Executive Function-Global Cognition
Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.
Measured: 16 weeks
Executive Function-Working Memory
Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test
Measured: 16 weeks
Executive Function-Episodic Memory
Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test
Measured: 16 weeks
Executive Function-Semantic Fluency
Assess semantic fluency of High-Intensity Interval Training (HIIT) to attention controls participants using the category fluency test
Measured: 16 weeks
Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity
Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)
Measured: 16 weeks
Secondary outcomes (2)
Cardio Fitness-maximal aerobic capacity
Cardiorespiratory fitness will be measured through a VO2 max test
Measured: 16 weeks
Cardio Fitness-maximal power output
Cardiorespiratory fitness will be measured through a VO2 max test
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start14 Jul 2021
- Primary completion9 Jun 2026
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Institute for Cancer Research
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724499
- Sponsor's protocol ID
- 20-222
- Acronym
- CLARITY
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2021
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Wilson 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.
PubMed 37027186
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)
- ClinicalTrials.gov ID
- NCT04724499
- Acronym / sponsor ID
- CLARITY / 20-222
- Conditions
- Breast Cancer, Chemotherapy Effect, Exercise Therapy, Cognitive Change
- Keywords
- Breast Cancer, Chemotherapy Effect, Exercise Therapy, Cognitive Change
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Institute for Cancer Research
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 starting chemotherapy either before (pre-operative or neoadjuvant) or after surgery (post-operative or adjuvant)
This research study is a Pilot Study, which is the first-time investigators are examining this intervention in this setting. The study is trying to determine whether participating in a specific exercise program can improve brain and heart function, as there is some evidence that there can be cognitive changes after chemotherapy among some patients with breast cancer. This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for breast cancer.
Participants will be randomly assigned to one of two groups:
- Group A: High Intensity Interval Training (HIIT) for 16 weeks
- Group B: Attention Control for 16 weeks home-based stretching; the HIIT intervention will be available after the study ends
The research study procedures include screening for eligibility and study treatment including extensive evaluations of your fitness and brain health, including MRI, blood tests, bone scans, fitness and strength assessments, and surveys at study entry and follow up visits.
Participants will receive study treatment for 4 months and will be followed for 4 months.
The total time for participation in this study will be about 8 months.
It is expected that about 30 people will take part in this research study.
The American Institute for Cancer Research is supporting this research by providing funding for the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Intervals Training | Experimental | Behavioral: High-Intensity Intervals TrainingParticipants 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. |
| Attention Control | Active comparator | Other: Attention ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Intervals Training16 week exercise program with stationary bike. | Behavioural | High-Intensity Intervals Training |
| Attention Control16 week stretching program. | Other | Attention Control |
Primary outcome
Executive Function and Attention
Time frame: 16 weeks
Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.
Executive Function-Global Cognition
Time frame: 16 weeks
Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.
Executive Function-Working Memory
Time frame: 16 weeks
Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test
Executive Function-Episodic Memory
Time frame: 16 weeks
Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test
Executive Function-Semantic Fluency
Time frame: 16 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) connectivity
Time frame: 16 weeks
Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)
2 secondary outcomes
Cardio Fitness-maximal aerobic capacity
Time frame: 16 weeks
Cardio Fitness-maximal power output
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 37027186Wilson 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.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Dieli-Conwright, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Intervals Training in people with Breast Cancer and Chemotherapy Effect, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Function and Attention (time frame: 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04724499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.