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

May 13, 2021 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group
The treatment group receive topical treatment of Ru-Yi-Jin-Huang Powder.
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.
NO_INTERVENTION: Control group
The control group receive regular management for radiation-induced dermatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of VAS score from baseline and 2 months
Time Frame: VAS score is assessed by physicians 2 times a week, up to 8 weeks.
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
Time Frame: CTCAE is assessed by physicians once a week with photos following, up to 8 weeks.
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
Time Frame: Skindex-16 is assessed by physicians once a week, up to 8 weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 8, 2021

Primary Completion (ANTICIPATED)

July 30, 2022

Study Completion (ANTICIPATED)

July 30, 2022

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (ACTUAL)

May 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202000655A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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