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High-Intensity Interval Training for Cognitive Function in Breast Cancer Patients (CLARITY Trial)

N/A

Recruiting

Led By Christina Dieli-Conwright, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women newly diagnosed (Stage I-III) breast cancer

Have not experienced a weight reduction ≥10% within the past 6 months

Must not have

Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies

Patients with other active malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether HIIT can help improve brain health and cardiovascular function in women undergoing chemotherapy.

Who is the study for?

This trial is for women over 18 with early-stage breast cancer (Stage I-III) who will undergo chemotherapy, do less than an hour of exercise a week, don't smoke, and can travel to DFCI for assessments. They must not be pregnant or have lost significant weight recently, and if they can become pregnant, they need to use birth control and take a pregnancy test.

What is being tested?

The study is testing whether a 16-week program of High-Intensity Interval Training (HIIT) can improve brain health and heart function in women receiving chemotherapy for breast cancer. Participants are randomly assigned to either the HIIT program or an attention control group.

What are the potential side effects?

While specific side effects of HIIT aren't detailed here, high-intensity exercise may cause muscle soreness, fatigue, increased heart rate during activity, risk of injury if not properly supervised or executed with correct form.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman with newly diagnosed Stage I-III breast cancer.

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I have not lost 10% or more of my weight in the last 6 months.

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I am over 18 years old.

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I will be getting chemotherapy before or after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart disease or heart failure.

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I have another active cancer besides the one being studied.

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I do not have any uncontrolled illnesses like infections or diabetes.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Executive Function and Attention

Executive Function-Episodic Memory

Executive Function-Global Cognition

+3 more

Secondary study objectives

Cardio Fitness-maximal aerobic capacity

Cardio Fitness-maximal power output

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High-Intensity Intervals TrainingExperimental Treatment1 Intervention

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.

Group II: Attention ControlActive Control1 Intervention

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.

0 / 8Eligibility criteria met