Trials / Completed
CompletedNCT04361240
Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 172 (actual)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This is a companion study to the "Pragmatic Randomized Trial of Proton vs Photon Therapy for Patients with non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RadComp) Consortium Trial" (NCT02603341). The investigators will collect cardiovascular (CV) biomarkers and echocardiograms prior to, during, and for up to 1 year following radiation for a subset of patients enrolled on RadComp and to evaluate the impact of proton vs photon radiation therapy (RT) on CV function and structure.
Detailed description
The study population of the companion study will consist of newly enrolled RadComp trial participants. Patients on this ancillary will be consented prior to RadComp randomization to decrease the bias secondary to RT type and enhance internal validity. The study will define the early changes in biomarkers, imaging measures, and RT dose volume metrics and long-term (5-10 year) CV clinical outcomes using the RadComp parent study's infrastructure for clinical data collection and long-term follow-up. Blood samples, echocardiograms, and questionnaires are obtained at baseline (between end of chemotherapy and start of RT), immediately after the end of RT, and at 6 months and 12 months after the end of RT. An additional blood sample will be collected at 4 weeks after the start of RT. Clinical, demographic, and patient reported outcomes data are collected as part of the RadComp parent study. In addition to data collected by RadComp, we will collect a limited set of clinical data and two additional quality of life instruments for the companion study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Proton vs Photon Radiation | Assignment to proton vs photon by randomization on RadComp parent study. |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2025-05-29
- Completion
- 2025-05-29
- First posted
- 2020-04-24
- Last updated
- 2026-02-09
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04361240. Inclusion in this directory is not an endorsement.