JPRN-jRCT1032230451
Recruiting
Phase 2
Phase II Pilot Study of the Efficacy and Safety of StrataXRT forRadiation Dermatitis in Breast Cancer Patients with Postoperative Radiation Therapy
Ogita Mami0 sites50 target enrollmentNovember 19, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Ogita Mami
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •(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
Outcomes
Primary Outcomes
Not specified
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Unknown
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