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

Primary Purpose

Breast Cancer, Chemotherapy Effect, Exercise Therapy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Intensity Intervals Training
Attention Control
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Chemotherapy Effect, Exercise Therapy, Cognitive Change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-Intensity Intervals Training

Attention Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Executive Function and Attention
Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.
Executive Function-Global Cognition
Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.
Executive Function-Working Memory
Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test
Executive Function-Episodic Memory
Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test
Executive Function-Semantic Fluency
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
Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)

Secondary Outcome Measures

Cardio Fitness-maximal aerobic capacity
Cardiorespiratory fitness will be measured through a VO2 max test
Cardio Fitness-maximal power output
Cardiorespiratory fitness will be measured through a VO2 max test

Full Information

First Posted
January 19, 2021
Last Updated
July 20, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
American Institute for Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT04724499
Brief Title
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy
Acronym
CLARITY
Official Title
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
American Institute for Cancer Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapy Effect, Exercise Therapy, Cognitive Change
Keywords
Breast Cancer, Chemotherapy Effect, Exercise Therapy, Cognitive Change

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-Intensity Intervals Training
Arm Type
Experimental
Arm 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.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
High-Intensity Intervals Training
Intervention Description
16 week exercise program with stationary bike.
Intervention Type
Other
Intervention Name(s)
Attention Control
Intervention Description
16 week stretching program.
Primary Outcome Measure Information:
Title
Executive Function and Attention
Description
Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.
Time Frame
16 weeks
Title
Executive Function-Global Cognition
Description
Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.
Time Frame
16 weeks
Title
Executive Function-Working Memory
Description
Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test
Time Frame
16 weeks
Title
Executive Function-Episodic Memory
Description
Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test
Time Frame
16 weeks
Title
Executive Function-Semantic Fluency
Description
Assess semantic fluency of High-Intensity Interval Training (HIIT) to attention controls participants using the category fluency test
Time Frame
16 weeks
Title
Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity
Description
Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Cardio Fitness-maximal aerobic capacity
Description
Cardiorespiratory fitness will be measured through a VO2 max test
Time Frame
16 weeks
Title
Cardio Fitness-maximal power output
Description
Cardiorespiratory fitness will be measured through a VO2 max test
Time Frame
16 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Dieli-Conwright, MD
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Norris, MS
Phone
857-215-0195
Email
maryk_norris@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, MD
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

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

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