Clinical trial NCT04724499: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Chemotherapy Effect
Exercise Therapy
Cognitive Change
Keywords: Breast Cancer
Chemotherapy Effect
Exercise Therapy
Cognitive Change
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Institute for Cancer Research
First posted: 2021-01-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Executive Function and Attention
timeFrame: 16 weeks
measure: Executive Function-Global Cognition
timeFrame: 16 weeks
measure: Executive Function-Working Memory
timeFrame: 16 weeks
measure: Executive Function-Episodic Memory
timeFrame: 16 weeks
measure: Executive Function-Semantic Fluency
timeFrame: 16 weeks
measure: Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity
timeFrame: 16 weeks
Secondary outcomes:
measure: Cardio Fitness-maximal aerobic capacity
timeFrame: 16 weeks
measure: Cardio Fitness-maximal power output
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, MD
role: PRINCIPAL_INVESTIGATOR
References: