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Aerobic Exercise for Cardiovascular Protection in Breast Cancer Patients (EXACT2 Trial)
N/A
Waitlist Available
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore whether exercise can help protect the hearts of breast cancer patients receiving chemotherapy that is known to damage heart health.
Who is the study for?
The EXACT2 trial is for adults over 18 with stages I-III breast cancer who are about to start chemotherapy that can harm the heart. Participants must be cleared by a cardiologist and able to do a 12-week home-based aerobic exercise program. It's not for those with cognitive issues or conditions that make exercise unsafe.
What is being tested?
This study tests if regular aerobic exercise can protect the hearts of breast cancer patients from damage caused by anthracycline-based chemotherapy, which is known to potentially lead to heart failure.
What are the potential side effects?
While this trial focuses on exercising, potential side effects aren't detailed here but may include typical reactions related to physical activity such as muscle soreness, fatigue, or injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Left Ventricular (LV) Function
Secondary study objectives
Change in Aerobic Fitness
Change in Blood biomarkers
Change in Cardiac Electrical Activity
+2 moreAwards & 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: ExerciseExperimental Treatment1 Intervention
Participants will receive standard of care treatment for their breast cancer plus be given a 12-week home based aerobic exercise program.
Group II: ControlActive Control1 Intervention
Participants will receive standard of care treatment for their breast cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic exercise
2000
Completed Phase 2
~1130
Find a Location
Who is running the clinical trial?
Canadian Cancer Society (CCS)OTHER
81 Previous Clinical Trials
41,408 Total Patients Enrolled
7 Trials studying Breast Cancer
531 Patients Enrolled for Breast Cancer
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,518,066 Total Patients Enrolled
11 Trials studying Breast Cancer
4,730 Patients Enrolled for Breast Cancer
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,555 Total Patients Enrolled
4 Trials studying Breast Cancer
143 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be set to get a specific type of chemotherapy called AC-based chemotherapy with a certain minimum dose.You must be at least 18 years old to participate in this study.You can do a 12-week exercise program at home that gradually gets more challenging.You have been diagnosed with early to mid-stage breast cancer and have not yet started treatment.You have major problems with thinking and understanding.You have a medical condition that would make it unsafe for you to do aerobic exercise.You have been diagnosed with early-stage breast cancer and have not yet started treatment.You are going to receive a specific type and dose of chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Exercise
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.
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