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

Kyung Hee University0 个研究点目标入组 80 人开始时间: 待定最近更新: 2019年5月20日

适应症

试验速览

暂无简介。

•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

发起方