Efficacy and safety of low-power lasers for oral mucositis

JRCT ID: jRCTs062220069

Registered date:10/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hematopoietic malignancies requiring allogeneic/autologous hematopoietic stem cell transplantation
• Date of first enrollment: 05/12/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): A low-power laser (Diode Laser Sheep 810: wavelength 650 nm, power 40 mW, energy density 2 J/cm2 per 1 cm square area, 2 seconds per point) is irradiated into the patient's mouth by a dentist three times a week for three weeks from the day of pretreatment high-dose chemotherapy administration.

Outcome(s)

• Primary Outcome: Percentage of patients who developed Grade 2 or higher oral mucositis according to NCI-CTCAE ver 5.0

Secondary Outcome

Numerical Rating Scale(NRS)
Number of days of use of mouthwash containing analgesics/local anesthetics
Oral score using the Oral Environment Assessment and Oral Infection Source Risk Assessment
Inflammation area of periodontal tissue by periodontal histology PISA
Oral bacterial count
Oral dryness (saliva test and mucus measurement)
Time to first occurrence of endodontic inflammation
Duration of each grade of oral mucositis
Oral mucositis assessment by NCICTCAE ver5.0, Oral Mucositis Assessment Scale (OMAS)
Oral flora analysis (analysis of the flora of all subjects based on the tongue)
Hematological examination (white blood cell count, white blood cell fraction, red blood cell count, hemoglobin, CRP, TP, Alb), blood culture
Inflammatory cytokines in saliva (IL1a,b, 6, 7, 8, 10, 18, IFNy, IP10, TNFa, VEGF, MIP1a,b)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(i) 18 years and older
(ii) Patients with hematopoietic malignancies who are scheduled for hematopoietic stem cell transplantation (not limited to first-line treatment)
(iii) No oral mucositis during the previous observation period
(iv) The patient must consent to the study

Exclude criteria

(i) Patients who have developed oral mucositis due to caries, dentures, or other irritations
(ii) Patients with a history of radiation therapy to the oral cavity
(iii) Other subjects deemed inappropriate by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Nishi Hiromi
• Secondary Sponsor: Kawaguchi Hiroyuki
• Source(s) of Monetary Support: Medical Health Division, Unitac Corporation