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
CRIS Registration Number |
KCT0006073 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 2 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | 202015X09 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Soon Chun Hyang University Hospital Cheonan |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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 |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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