Clinical trial · Interventional
Exercise to Prevent AnthraCycline-based Cardio-Toxicity Study 2.0 (EXACT2)
EXercise to Prevent AnthraCycline-based Cardio-Toxicity 2.0 (EXACT2) in Individuals With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Although great progress has been made in treating breast cancer, long-term health may be impaired by cancer therapy. For example, some chemotherapy drugs (e.g., anthracyclines) are known to cause declines in heart health. While the impact can vary, some will experience substantial heart damage that may lead to heart failure and death. As these treatments are highly effective, there is a need to find ways to reduce the damaging effects while not interfering with its anticancer potential. As it is well-known that regular exercise can improve heart health, the purpose of this study is to explore the role of exercise as a heart protective therapy for breast cancer patients receiving heart damaging chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
| Cardiovascular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants will receive standard of care treatment for their breast cancer.
- type
- EXPERIMENTAL
- label
- Exercise
- description
- Participants will receive standard of care treatment for their breast cancer plus be given a 12-week home based aerobic exercise program.
- interventionNames
- Behavioral: Aerobic exercise
Primary outcomes (1)
- measure
- Change in Left Ventricular (LV) Function
- timeFrame
- LV function will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
- description
- LV function will be assessed using serial transthoracic echocardiography (TTE) as well as tissue velocity imaging (TVI) and strain imaging (SI.) For 2-dimensional (2D) LV cavity dimensions and LVEF will be determined from the acquired 2D images according to established criteria. Tissue Doppler-derived indexes will be recorded at the base of the lateral mitral annuli to determine longitudinal endocardial velocities. The indexes that will be assessed are systolic (S'), early diastolic (e') and late diastolic (a') velocities. Doppler-independent strain will be assessed offline using semi-automated speckle tracking techniques. These will be performed using parasternal and apical views to determine both global longitudinal and radial strain.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) must be 18 years or older. * 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). * are able to undertake a 12-week home-based, progressive aerobic exercise program. * have medical clearance from a cardiologist (e.g. based on stress test results) to participate in the study. Exclusion Criteria: * significant cognitive limitations. * pre-existing medical condition that would otherwise contraindicate aerobic exercise.
References
Publications (0)
Data not yet available