Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder for the Radiation-induced Dermatitis.
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2021
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2021
CompletedFirst Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedMay 17, 2021
May 1, 2021
1.2 years
May 10, 2021
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Study Arms (2)
Treatment group
EXPERIMENTALThe treatment group receive topical treatment of Ru-Yi-Jin-Huang Powder.
Control group
NO INTERVENTIONThe control group receive regular management for radiation-induced dermatitis.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 17, 2021
Study Start
May 8, 2021
Primary Completion
July 30, 2022
Study Completion
July 30, 2022
Last Updated
May 17, 2021
Record last verified: 2021-05