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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
CLARITY Trial 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.Check my eligibility
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.See study design
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.
CLARITY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman with newly diagnosed Stage I-III breast cancer.
Select...
I have not lost 10% or more of my weight in the last 6 months.
Select...
I am over 18 years old.
Select...
I will be getting chemotherapy before or after surgery.
CLARITY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Executive Function and Attention
Executive Function-Episodic Memory
Executive Function-Global Cognition
+3 moreSecondary outcome measures
Cardio Fitness-maximal aerobic capacity
Cardio Fitness-maximal power output
CLARITY 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.
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,918 Total Patients Enrolled
American Institute for Cancer ResearchOTHER
10 Previous Clinical Trials
8,531 Total Patients Enrolled
Christina Dieli-Conwright, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
80 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Can start a workout program with supervision.I have a history of heart disease or heart failure.I am a woman with newly diagnosed Stage I-III breast cancer.I have not lost 10% or more of my weight in the last 6 months.You currently do less than 60 minutes of structured exercise per week.You do more than 60 minutes of planned exercise each week.I have another active cancer besides the one being studied.I am over 18 years old.You are afraid of being in small, enclosed spaces.You have physical limitations that prevent you from doing intense cycling exercises.I do not have any uncontrolled illnesses like infections or diabetes.My cancer has spread to other parts of my body.I will be getting chemotherapy before or after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: High-Intensity Intervals Training
- Group 2: Attention Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the clinical trial accommodating at maximum capacity?
"Affirmative. Information from clinicaltrials.gov indicates that recruitment efforts began on July 14th 2021 and were recently updated on July 5th 2022. This trial is hunting for 30 individuals to participate at a single centre."
Answered by AI
Are there any current opportunities to join this experiment?
"The clinical trial is still open for participation and has been actively recruiting since July 14th, 2021. The protocol was most recently revised on July 5th 2022 according to data hosted on clinicaltrials.gov."
Answered by AI
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