Effectiveness, safety study of a herbal ointment, Jaungo, for radiation dermatitis of breast cancer patients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003506

Enrollment

Registered

2019-02-14

Start date

2019-06-01

Completion date

Unknown

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Jaungo application: Hanpoong Jaungo, twice a day (morning & evening), 42 days, Local application on skin for radiation therapy Usual care: Washing skin for radiation therapy with clean water or

Eligibility

Sex/Gender

Female

Inclusion 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

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 11) Other inappropriate reasons for study participation, decided by primary or sub investigators

Design outcomes

Primary

Measure	Time frame
Radiation Therapy Oncology Group skin toxicity scale	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactDeok Sang Hwang

Kyung Hee University Oriental Medical Center

soulhus@gmail.com+82-2-958-9133

Outcome results