Evaluating heart health in women with breast cancer
Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients
This study is trying to find out how to better monitor and manage heart health in women with breast cancer who are receiving chemotherapy to improve their overall well-being.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | National University of Ireland, Galway, Ireland Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Galway and 3 other locations) |
| Trial ID | NCT05921279 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a Cardio-Oncology assessment and surveillance pathway for women diagnosed with stage I-III breast cancer who are undergoing systemic chemotherapy. The research focuses on identifying and managing the cardiovascular side effects of cancer treatments, which can significantly impact the quality of life and overall health outcomes for these patients. By collaborating with biostatisticians, the study will collect and analyze data on health-related quality of life and physical activity at various intervals throughout the treatment process. The ultimate goal is to inform the development of clinical services that can better support breast cancer patients at risk of heart disease.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older diagnosed with stage I-III breast cancer who are planned to receive systemic chemotherapy.
Not a fit: Patients who are not receiving systemic chemotherapy with curative intent or those unable to cooperate with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cardiovascular health in breast cancer survivors, enhancing their quality of life and survival rates.
How similar studies have performed: While this approach is innovative, similar studies in cardio-oncology have shown promise in managing cardiovascular risks in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged ≥ 18 years * Ability to read and understand English * Breast Cancer Stage I- III planned to receive systemic chemotherapy Exclusion Criteria: * Patients not for systemic chemotherapy with curative intent * Patients who are unable to co-operate with the study protocol * Patients who are unable to give informed consent
Where this trial is running
Galway and 3 other locations
- Galway University Hospital — Galway, Ireland (Recruiting)
- Galway Clinic — Galway, Ireland (Recruiting)
- Mayo University Hospital — Mayo, Ireland (Recruiting)
- Sligo General Hospital — Sligo, Ireland (Recruiting)
Study contacts
- Principal investigator: Osama Soliman, MBBCh, PhD — Nuig
- Study coordinator: Osama Soliman, MBBCh, PhD
- Email: osama.soliman@nuigalway.ie
- Phone: +35391493781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.