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Evaluation of efficacy and safety of low-level laser therapy for cancer therapy-induced oral mucositis

Status Approved

  • First Submitted Date

    2021/03/20

  • Registered Date

    2021/04/09

  • Last Updated Date

    2021/04/19

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006073
    Unique Protocol ID 2020-06-032
    Public/Brief Title Evaluation of efficacy and safety of low-level laser therapy for cancer therapy-induced oral mucositis
    Scientific Title Evaluation of efficacy and safety of low-level laser therapy for cancer therapy-induced oral mucositis
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SCHCA 2020-06-032
    Approval Date 2020-06-24
    Institutional Review Board Name Soon chun hyang University Hospital Institutional Review Board
    Institutional Review Board Address 31, Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do
    Institutional Review Board Telephone 041-570-2985
    Data Monitoring Committee Yes
    Institutional Review Board of Soonchunhyang University Cheonan Hospital
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jung Eun Kim
    Title Assistant professor
    Telephone +82-41-570-2270
    Affiliation Soon Chun Hyang University Hospital Cheonan
    Address 31, Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea
    Contact Person for Public Queries
    Name Jung Eun Kim
    Title Assistant professor
    Telephone +82-41-570-2270
    Affiliation Soon Chun Hyang University Hospital Cheonan
    Address 31, Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea
    Contact Person for Updating Information
    Name Jung Eun Kim
    Title Assistant professor
    Telephone +82-41-570-2270
    Affiliation Soon Chun Hyang University Hospital Cheonan
    Address 31, Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-04-09 Actual
    Target Number of Participant 60
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Soon Chun Hyang University Hospital Cheonan
    Recruitment Status Recruiting
    Date of First Enrollment 2021-04-09 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Soon Chun Hyang University Hospital Seoul
    Recruitment Status Recruiting
    Date of First Enrollment 2021-04-09 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID 202015X09
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Soon Chun Hyang University Hospital Cheonan
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1. Purpose and background of the clinical trial
    
    1) Purpose of clinical trial
    Evaluation of safety and effectiveness of medical laser device(PetalB laser device) in patients with oral disease: A multi-center, single group study
    
    2) Background of the clinical trial
    ○ Low-level laser therapy(LLLT) has been revealed to have various effects such as anti-inflammatory effects, pain control, immune promotion, neurodevelopment, sensitivity mitigation, sterilization, anti-epidemic, and blood circulation, and is known to have a wide range of clinical applications. The LLLT transmits light energy inside to body by transmitting the surface of the skin without any damage without generating heat (1~500nW). Body cells that absorb laser light, turn light energy into chemical energy that can heal cell damage, which is called the bio-stimulation effect.
    
    ○ In this study, patients who develop oral mucositis (WHO mucositis scale, grade 2 or higher) with concurrent chemoradiation therapy or chemotherapy are required to conduct prospective exploratory clinical trials to ensure the safety and effectiveness of PetalB. WHO mucositis scale, a primary efficacy evaluation tool, can be measured numerically and objectively to check the militancy of mouth mucositis, which can be validated by comparison before and after treatment without a control group. Soheir et al. (2019) also use WHO mucositis scale as an evaluation variable to evaluate the improvement of objective oral mucositis before and after treatment in a single group, referring to these existing studies, to compare the rate of oral mucositis grade 2 or higher.
    
    3. Clinical trial period
    The period of this clinical trial shall be one and a half years from the date of approval of the clinical trial plan. The estimated time required for each step is as follows.
    - 8 months of recruitment period for subjects
    - 2~3 months for clinical observation and testing of subjects (8~12 weeks)
    - 2 months of clinical results analysis and report preparation 
    
    However, if circumstances occur that may affect the progress of clinical trials, there may be changes in the period.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Medical Device  
    Intervention Description
    The subject visits the clinical trial institution three to for times during chemotherapy or concurrent chemoradiotherapy (for4 to 6 weeks), and applies the clinical device (PetalB laser instrument) during 20 minitues for each visit
    Number of Arms 1
    Arm 1

    Arm Label

    patients with oral mucositis (more than WHO grade 2) after chemotherapy or concurrent chemoradiotherapy

    Target Number of Participant

    60

    Arm Type

    Experimental

    Arm Description

    The subject visits the clinical trial institution three to four times during chemotherapy or concurrent chemoradiotherapy (for4 to 6 weeks), and applies the clinical device (PetalB laser instrument) during 20 minitues for each visit
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (Z00-Z99)Factors influencing health status and contact with health services 
       (Z51.2)Persons encountering health services for other chemotherapy 

    Mucositis/Low-Level Light Therapy
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~80Year

    Description

    - Those who have been diagnosed with cancer in one organ and is receiving chemotherapy or concurrent chemo-radiotherapy
    - Those with WHO mucositis scale grade 2 or higher
    - Adults over 19 years old
    - Those who have no problem expressing their opinions
    - Those who voluntarily participated and signed the subject's consent of this clinical trial
    Exclusion Criteria
    - Pregnants, Those who have a mental disorder
    - Those who are diagnosed with double primary cancer or distant metastasis with unknown origin
    - Those who have trouble with mouth opening (difficult to open mouth more than 1cm2)
    - Those who have uncontrolled connective tissue disorder
    - Smokers
    - Those who have received light-based treatment within the last 6 weeks
    - Those who are sensitive to laser light or taking medications that are related to laser light sensitivity
    - Those who have participated in another clinical trial within the last month
    - Those who have difficulty to participate in a clinical trial or receive treatment 
    - Those who have been thought the clinical trials cannot be performed properly
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    primary endpoint: comparison of the ratio of moderate to severe oral mucositis (more than WHO grade 2) before treatment and after treatment
    Timepoint
    Before treatment, 2 weeks±3 days after treatment,  4 weeks±3 days after treatment
    Secondary Outcome(s) 1
    Outcome
    secondary endpoint: Comparison of European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30) scores before and after treatment
    Timepoint
    Before treatment, 2 weeks±3 days after treatment,  4 weeks±3 days after treatment
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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