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Aerobic Exercise for Cardiovascular Protection in Breast Cancer Patients (EXACT 2 Trial)

N/A
Recruiting
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
Diagnosed with breast cancer (stages I-III) and not have started therapy
Must be scheduled to receive AC-based chemotherapy (minimum dose of 240 mg/m2 of DOX or 300 mg/m2 of DAN)
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

EXACT 2 Trial 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.Check my eligibility
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.See study design
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.

EXACT 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with early-stage breast cancer and have not yet started treatment.
Select...
You are going to receive a specific type and dose of chemotherapy.

EXACT 2 Trial 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Left Ventricular (LV) Function
Secondary outcome measures
Change in Aerobic Fitness
Change in Blood biomarkers
Change in Cardiac Electrical Activity
+2 more

EXACT 2 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
77 Previous Clinical Trials
37,516 Total Patients Enrolled
7 Trials studying Breast Cancer
531 Patients Enrolled for Breast Cancer
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,333 Previous Clinical Trials
25,747,258 Total Patients Enrolled
10 Trials studying Breast Cancer
4,218 Patients Enrolled for Breast Cancer
Nova Scotia Health AuthorityLead Sponsor
254 Previous Clinical Trials
83,039 Total Patients Enrolled
4 Trials studying Breast Cancer
286 Patients Enrolled for Breast Cancer

Media Library

Aerobic exercise Clinical Trial Eligibility Overview. Trial Name: NCT03748550 — N/A
Breast Cancer Research Study Groups: Control, Exercise
Breast Cancer Clinical Trial 2023: Aerobic exercise Highlights & Side Effects. Trial Name: NCT03748550 — N/A
Aerobic exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03748550 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being accepted for this clinical experimentation?

"According to clinicaltrials.gov, this particular trial is no longer enrolling participants as the last update noted was on November 19th 2018, from when it first posted in July of 2019. However, there are still 3,031 other medical studies currently accepting volunteers."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
~17 spots leftby Mar 2025