Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder for the Radiation-induced Dermatitis.
Primary Purpose
Radiation Dermatitis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ru-Yi-Jin-Huang Powder
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Dermatitis focused on measuring Radiation 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
The treatment group receive topical treatment of Ru-Yi-Jin-Huang Powder.
The control group receive regular management for radiation-induced dermatitis.
Outcomes
Primary Outcome Measures
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'.
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.
Change of Skindex-16 from baseline and 2 months
The scale is a brief quality-of-life measure for patients with skin diseases.
Secondary Outcome Measures
Full Information
NCT ID
NCT04888234
First Posted
May 10, 2021
Last Updated
May 13, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04888234
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2021 (Anticipated)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
Keywords
Radiation dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The treatment group receive topical treatment of Ru-Yi-Jin-Huang Powder.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group receive regular management for radiation-induced dermatitis.
Intervention Type
Drug
Intervention Name(s)
Ru-Yi-Jin-Huang Powder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of VAS score from baseline and 2 months
Description
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'.
Time Frame
VAS score is assessed by physicians 2 times a week, up to 8 weeks.
Title
Change of CTCAE version 4 from baseline and 2 months
Description
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.
Time Frame
CTCAE is assessed by physicians once a week with photos following, up to 8 weeks.
Title
Change of Skindex-16 from baseline and 2 months
Description
The scale is a brief quality-of-life measure for patients with skin diseases.
Time Frame
Skindex-16 is assessed by physicians once a week, up to 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zi-Yu Chang
Phone
+886-224313131
Ext
2127
Email
changzhi887@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder for the Radiation-induced Dermatitis.
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