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

Radiation Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04888234
• Other study ID #: 202000655A3
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 8, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: May 2021
• Source: Chang Gung Memorial Hospital
• Contact: Zi-Yu Chang
• Phone: +886-224313131
• Email: changzhi887[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Drug:
• Ru-Yi-Jin-Huang Powder
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.