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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
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation Dermatitis focused on measuring Radiation dermatitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 10, 2021
    Last Updated
    May 13, 2021
    Sponsor
    Chang Gung Memorial Hospital
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    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

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