Breast Cancer Breast Cancer
Conditions
Interventions
Application of StrataXRT
StrataXRT, Breast Cancer, Radiation Dermatitis
Sponsors
Ogita Mami
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Patients who have pathological diagnosis of breast cancer (2) Patients who plan to undergo whole breast irradiation after lumpectomy or post-mastectomy radiotherapy (3) Patients who are eligible for radiotherapy (4) Patients with Performance Status (PS) of 0 to 2 (5) Female patients aged 18 years old or older (6) Patients who have provided written consent (7) Outpatient
Exclusion criteria
Exclusion criteria: (1) Patients with distant metastasis (2) Patients with a history of radiation therapy to the treatment area (3) Patients requiring concurrent bilateral breast radiation (4) Patients requiring partial breast radiation (5) Patients with active rash, pre-existing dermatitis, or any skin conditions within the treatment area that prevents skin assessment for the study (6) Patients who are allergic to silicone (7) Patients participating in other clinical trials (8) Patients whom the Principal Investigator or Co-Investigator has determined to be unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 2 or higher acute radiation dermatitis (CTCAE), completion rate of StrataXRT therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute adverse events, StrataXRT compliance, patient-reported outcomes, provider-reported outcomes, moist desquamation, dermatitis with imaging, QOL, StrataXRT adverse events, topical steroid use, satisfaction | — |
Contacts
Public ContactTakuya Hayashi
The University of Tokyo Hospital
Outcome results
None listed