Laser for prevention of oral mucositis and safety in patients undergoing hematopoietic stem cell transplantation

JRCT ID: jRCTs072240122

Registered date:06/03/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who will undergo hematopoietic stem cell transplantation
• Date of first enrollment: 06/03/2025
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Laser irradiation or false laser irradiation of the oral mucosa.

Outcome(s)

Primary Outcome

Incidence of grade 2 oral mucositis
Days from the start of pretreatment to the onset of grade 2 oral mucositis

Secondary Outcome

Incidence of grade 1,3,4 and 5 oral mucositis
Days from the start of pretreatment to the onset of grade 1,3,4 and 5 oral mucositis

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients scheduled to undergo hematopoietic stem cell transplantation at Nagasaki University Hospital
(2) Patients who are 18 years of age or older (regardless of gender) at the time of consent
(3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding

Exclude criteria

(1) Patients with or with a history of cancer in the oral cavity
(2) Patients with a cardiac pacemaker
(3) Patients who cannot open their mouth sufficiently
(4) Patients who already have oral mucositis at the time of consent
(5) Patients who are participating in a clinical trial or other clinical research
(6) Other patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Yoshimatsu Masako