Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder for the Radiation-induced Dermatitis.

• Status: Not yet recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

Summary

Radiation-induced dermatitis is the most common complication of radiotherapy for cancer treatment. However, there is no satisfactory management to deal with the problem. Ru-Yi-Jin-Huang Powder is one of most common topical TCM drug to treat skin diseases but lack of evidence to support efficacy. The aim of this trial is to evaluate the effectiveness of Ru-Yi-Jin-Huang Powder for radiation-induced dermatitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital

Criteria

Inclusion Criteria:

• stage 3 or 4 of head and neck cancer or nasopharyngeal cancer with pathological confirmed malignancy undergoing concurrent chemoradiotherapy more than 20 times or radiation dermatitis > CTCAE grade 2.

• more than 18 years old.

• VAS score > 6 with poor response to narcotics.

• estimated survival time of > 6 months.

• be suitable for TCM topical treatment after evaluation by TCM physicians.

• willingness to joint this trial and sign consent form of study.

Exclusion Criteria:

• non-head and neck cancer or have not receive CCRT.

• not be suitable for Ru-Yi-Jin-Huang topical treatment after TCM physicians evaluation.

• history of allergy to TCM topical use.

• poor conscious to answer questionnaires.

• pregnancy.

• KPS < 30.