KCT0003506
Not yet recruiting
未知
Effectiveness, safety, and economic evaluation of topical application of a herbal ointment, Jaungo, for radiation dermatitis after breast conserving surgery in patients with breast cancer: a prospective, randomized, open-label, parallel-group, clinical trial
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Kyung Hee University
- Enrollment
- 80
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Female between 19 and 80 years old
- •2\) Unilateral breast cancer confirmed by biopsy
- •3\) Planned radiation therapy with dose of 50 – 64 Gy, without bolus, after breast conserving surgery
- •4\) ECOG performance status grade \= 1
- •5\) Voluntarily signed the written/informed consent after getting full explanation about this trial
Exclusion Criteria
- •1\) Confirmed inflammatory breast cancer
- •2\) Skin invasion or distant metastasis of tumor
- •3\) Concurrent chemotherapy with radiation therapy, except for herceptin and hormone therapy
- •4\) Untreated wounds, existing burn/injury which is severe or extensive, dampness, erosion, or suppuration on breast skin \& high fever
- •5\) A history of prior RT to the chest wall,
- •6\) A history of connective tissue disorders
- •7\) A history of heart diseases like arrhythmia, uncontrolled hypertension, severe mental disorders (dementia, drug addiction, etc.) which need treatments, or paralysis
- •8\) A history of hypersensitivity reaction to study drug or it’s ingredients
- •9\) Participation in other trials within a month
- •10\) Disagreement with contraception during study period
Outcomes
Primary Outcomes
Not specified
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