Clinical trial NCT04888234: Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder for the Radiation-induced Dermatitis.
Official title: Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder for the Radiation-induced Dermatitis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Radiation Dermatitis
Keywords: Radiation dermatitis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The common management of head and neck cancer are concurrent chemoradiotherapy (CCRT) after surgical section. Radiation-induced dermatitis is the most common complication of radiotherapy for cancer, affecting approximately 95 percent of patients receiving radiotherapy. The skin changes include erythema, edema, pigment changes, hair loss, and dry or moist desquamation. It may cause xerostomia, hard food taking, severe infection to delay the completion of course of treatment. Although, there are lots of topical drug to deal with radiation dermatitis, there is no best way to manage the skin problems. Ru-Yi-Jin-Huang Powder is one of most common topical TCM drug to treat skin ulcer, joint swelling or other infective or inflammatory diseases. Some study showed that Ru-Yi-Jin-Huang Powder can be used to decrease edema or swelling, pain relief, decrease phlebitis or mumps. However, there is no related evidence to support Ru-Yi-Jin-Huang Powder for radiation dermatitis. Thus, the aim of the study is to evaluate the effectiveness of Ru-Yi-Jin-Huang Powder for radiation-induced dermatitis.

Eligibility 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.

Primary outcomes:
measure: Change of VAS score from baseline and 2 months
timeFrame: VAS score is assessed by physicians 2 times a week, up to 8 weeks.
measure: Change of CTCAE version 4 from baseline and 2 months
timeFrame: CTCAE is assessed by physicians once a week with photos following, up to 8 weeks.
measure: Change of Skindex-16 from baseline and 2 months
timeFrame: Skindex-16 is assessed by physicians once a week, up to 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: