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

NCT ID: NCT04888234

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-08
• Study Completion Date: 2022-07-30

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.

Conditions

Radiation Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

The treatment group receive topical treatment of Ru-Yi-Jin-Huang Powder.

Group Type: EXPERIMENTAL

Ru-Yi-Jin-Huang Powder

Intervention Type: 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.

Control group

The control group receive regular management for radiation-induced dermatitis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zi-Yu Chang

Role: CONTACT

changzhi887@gmail.com

+886-224313131 ext. 2127

Other Identifiers

202000655A3

Identifier Type: -

Identifier Source: org_study_id