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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Drug: Ru-Yi-Jin-Huang Powder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>The treatment group receive topical treatment of Ru-Yi-Jin-Huang Powder. | Drug: Ru-Yi-Jin-Huang Powder<br>* Ru-Yi-Jin-Huang Powder is the most common TCM topical drug for skin diseases. It is often used to treat skin ulcers, sprain of joint with swelling, and other inflammatory diseases.<br>|
| No Intervention: Control group<br>The control group receive regular management for radiation-induced dermatitis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS score from baseline and 2 months | The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 0 of 'no pain at all' and 10 of 'pain as bad as it could be'. | VAS score is assessed by physicians 2 times a week, up to 8 weeks. | 
| Change of CTCAE version 4 from baseline and 2 months | The criteria is used for the management of chemoradiotherapy administration. and dosing, and to provide standardization and consistency in the definition of treatment-related toxicity. | CTCAE is assessed by physicians once a week with photos following, up to 8 weeks. | 
| Change of Skindex-16 from baseline and 2 months | The scale is a brief quality-of-life measure for patients with skin diseases. | Skindex-16 is assessed by physicians once a week, up to 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation dermatitis