Research on prevention of oral mucositis using sesame oil

JRCT ID: jRCT1030230334

Registered date:07/09/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: central nervous system lymphoma
• Date of first enrollment: 07/09/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): In HD-MTX therapy, the standard care for oral mucositis is brushing with a toothbrush and gargling with allopurinol gargling water. Therefore, we will compare two groups: a group gargles with allopurinol gargling water (control group) and a group gargles with allopurinol gargling water and sesame oil (intervention group).

Outcome(s)

• Primary Outcome: The severity of oral mucositis using CTCAE v5.0

Secondary Outcome

1. Inflammatory changes by oral mucosal cytology
2. Dry mouth, dysphagia, pain, taste changes, anorexia, and nausea using PRO-CTCAE as subjective evaluations by research subjects

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Persons aged 20 years or older who can write informed consent before starting treatment
2. Those receiving first-time HD-MTX therapy
3. Persons who are orally ingesting regular food (not soft vegetarian food, swallowing food, etc.)
4. Those with good oral conditions
5. Persons who are able to perform oral care on their own

Exclude criteria

1. Those with a history of long-term use of steroids, immunodeficiency, or diabetes
2. Those suffering from an infectious disease
3. Persons who are currently being treated for cancer in another location (if they have received treatment for cancer in another location in the past, those who have completed surgery, drug therapy, or radiation therapy for less than 2 years)
4. Persons who are allergic to sesame oil

Related Information

• Primary Sponsor: TADERA Noriyuki
• Source(s) of Monetary Support: JSPS Grant-in-Aid for Scientific Research(C)