RECRUITING

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

Conditions

Breast Cancer Chemotherapy Effect Exercise Therapy Cognitive Change

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2021-07-14

Study Completion:2025-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04724499

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Christina Dieli-Conwright, MD

CONTACT

617-582-8321

ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU

Mary Norris, MS

CONTACT

857-215-0195

maryk_norris@dfci.harvard.edu

Principal Investigator

Christina Dieli-Conwright, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Christina Dieli-Conwright, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-14

Study Completion Date2025-06-15

Study Record Updates

Study Start Date2021-07-14

Study Completion Date2025-06-15

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
Chemotherapy Effect
Exercise Therapy
Cognitive Change

Additional Relevant MeSH Terms

Breast Cancer
Chemotherapy Effect
Exercise Therapy
Cognitive Change