Effectiveness, safety study of a herbal ointment, Jaungo, for radiation dermatitis of breast cancer patients
- Conditions
- Neoplasms
- Registration Number
- KCT0003506
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 80
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
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
11) Other inappropriate reasons for study participation, decided by primary or sub investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiation Therapy Oncology Group skin toxicity scale
- Secondary Outcome Measures
Name Time Method Institute for Medical Technology Assessment Productivity Cost Questionnaire;Cost survey;Adverse events;Vital sign;Pain visual analog scale;Skindex-29;EuroQoL Five Dimensions questionnaire 5-Level