Boston, Massachusetts 02115

  • Cognitive Change

Purpose:

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)


Study summary:

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.


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.


Study is Available At:


Original ID:

20-222


NCT ID:

NCT04724499


Secondary ID:


Study Acronym:

CLARITY


Brief Title:

Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy


Official Title:

Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)


Overall Status:

Not yet recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dana-Farber Cancer Institute


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Christina Dieli-Conwright, MD
Principal Investigator
Dana-Farber Cancer Institute
Primary Contact:Christina Dieli-Conwright, MD
617-582-8321
ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU
Backup Contact:Mary Norris, MS
857-215-0195
maryk_norris@dfci.harvard.edu

Study Dates

Start Date:June 2021
Completion Date:June 15, 2023
Completion Type:Anticipated
Primary Completion Date:June 15, 2022
Primary Completion Type:Anticipated
Verification Date:May 2021
Last Changed Date:May 12, 2021
First Received Date:January 19, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Executive Function and Attention
Time Frame:16 weeks
Safety Issues:False
Description:Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.
Outcome Type:Primary Outcome
Measure:Executive Function-Global Cognition
Time Frame:16 weeks
Safety Issues:False
Description:Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.
Outcome Type:Primary Outcome
Measure:Executive Function-Working Memory
Time Frame:16 weeks
Safety Issues:False
Description:Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test
Outcome Type:Primary Outcome
Measure:Executive Function-Episodic Memory
Time Frame:16 weeks
Safety Issues:False
Description:Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test
Outcome Type:Primary Outcome
Measure:Executive Function-Semantic Fluency
Time Frame:16 weeks
Safety Issues:False
Description:Assess semantic fluency of High-Intensity Interval Training (HIIT) to attention controls participants using the category fluency test
Outcome Type:Primary Outcome
Measure:Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity
Time Frame:16 weeks
Safety Issues:False
Description:Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)
Outcome Type:Secondary Outcome
Measure:Cardio Fitness-maximal aerobic capacity
Time Frame:16 weeks
Safety Issues:False
Description:Cardiorespiratory fitness will be measured through a VO2 max test
Outcome Type:Secondary Outcome
Measure:Cardio Fitness-maximal power output
Time Frame:16 weeks
Safety Issues:False
Description:Cardiorespiratory fitness will be measured through a VO2 max test

Study Interventions

Intervention Type:Other
Name:Attention Control
Description:16 week stretching program.
Arm Name:Attention Control
Intervention Type:Behavioral
Name:High-Intensity Intervals Training
Description:16 week exercise program with stationary bike.
Arm Name:High-Intensity Intervals Training

Study Arms

Study Arm Type:Experimental
Arm Name: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
Study Arm Type:Active Comparator
Arm Name: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dana-Farber Cancer Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Institute for Cancer Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

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