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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | The treatment group receive topical treatment of Ru-Yi-Jin-Huang Powder. |
|
| Control group | No Intervention | The control group receive regular management for radiation-induced dermatitis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ru-Yi-Jin-Huang Powder | Drug | 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zi-Yu Chang | Contact | +886-224313131 | 2127 | changzhi887@gmail.com |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| D014947 |
| Wounds and Injuries |