Exploratory study to investigate the efficacy of a novel mucosal protection method for oral mucositis

JRCT ID: jRCTs062220084

Registered date:19/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral mucositis
• Date of first enrollment: 30/03/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

In addition to conventional oral care centered on moisturizing, the test device is filled onto the affected tooth causing mucous membrane damage.
The blister packaged product (single-use) will be removed from the package before use and filled directly onto the affected tooth with a glove (to be described in the attached document, etc.: a nitrile glove, etc. that is non-sticky and easy to shape is recommended) or other glove-wearing hand or fingers. The excess portion is removed and the subject is asked to bite the tooth, after which light irradiation is used to initiate polymerization and cure the tooth. If an undercut cannot be obtained due to dentition morphology or gingival shape, the test device is placed on the tooth in combination with a bonding material.
The affected tooth should be filled with the device during the treatment period from the day the procedure is performed (Day 1) to Day 15. If the device is removed from the affected tooth for any reason prior to Day 15, the subject will be instructed to return to the clinic immediately.
The subject will be instructed to come to the clinic as soon as possible after the scheduled evaluation at the end of the treatment period (filling day 15) to have the device removed from the affected tooth.
If the device falls out before the end of the treatment period (filling day 15), the affected tooth will be re-filled with the device and the date of re-filling will be recorded. However, if the research subject removes the device at his/her own discretion and does not wish to have another filling, or if the continuation of filling is deemed undesirable due to the development of disease, etc., or if any of the discontinuation criteria apply, the re-filling will not be performed.
If the subject does not wish to continue filling the device by the end of the treatment period (filling day 15), or if the subject has developed a disease that makes it undesirable to continue filling the device, or if any of the discontinuation criteria apply, the refilling of the device will be discontinued based on ethical and safety considerations for the research subject. (5)), the device will be removed from the affected tooth and an evaluation will be performed at the time of discontinuation, based on ethical and safety considerations for the research subjects.

Outcome(s)

Primary Outcome

1) Grade of oral mucositis, oral pain, etc.
(Grade evaluation based on CTCAE v5.0/MedDRA/J v25.1)

2) Sub-Criteria for Oral Mucositis according to CTCAE v3.0

3) PRO-CTCAE v1.0 [Patient Evaluation].

Secondary Outcome

1) Adjunctive therapy (abortive anti-inflammatory analgesic)
2) QOL evaluation [patient evaluation]: EORTC QLQ-C30, EORTC QLQ-OH15
3) Evaluation of oral condition: OHAT
4) Site of onset of oral mucositis
5) Technical effectiveness based on procedure-related surveys
6) Patient preference for continued treatment [patient evaluation
7) Breeding on biofilm on the surface of the test device
8) Saliva examination

Key inclusion & exclusion criteria

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

Include criteria

Patients who meet all the following criteria will be considered for this study
1) Clinically diagnosed oral mucositis (site of onset: lip or tongue) with contact to the cut or sharp edges of the teeth associated with cancer chemotherapy (including molecular targeted drugs)
2) Grade rating of oral mucositis and oral pain as per CTCAE v5.0/MedDRA/J v25.1 as Grade 2 or 3
3) Patient is receiving concomitant cancer chemotherapy or has completed (or is scheduled to complete) a full course of chemotherapy as of the start of the treatment period (Day 1).
However, if the chemotherapy is to be started during the drug withdrawal period between courses, the patient is not eligible for the above. In such cases, the schedule for the start of the treatment period (Day 1) of this study should be adjusted so that the chemotherapy is being administered concurrently. In addition, if there are plans to change the chemotherapy regimen, the change should be implemented prior to this study. In both cases, it is acceptable to confirm that other criteria are met before inclusion
4) Age 18 years or older at the time of consent
5) ECOG PS is 0 or 1
6) Functionally able to take food orally

Exclude criteria

Any of the following criteria shall not be included in this study
1) Patients undergoing head and neck radiation therapy, performed or scheduled to be performed as prior therapy
2) Patients scheduled for or undergoing hematopoietic cell transplantation
3) Present number of teeth: less than 10 teeth
4) Patients with edentulous jaws
5) Allergic to CPC or resin
6) Pregnant or possibly pregnant
7) Is or will be a user of mucous membrane protectants (Episil Oral Solution), medical narcotics, opioid preparations, steroid ointment for oral use (dexamethasone)
8) Has a dental treatment plan
9) Patients who are unable or unwilling to perform patient assessments properly under physician supervision
10) Other clinical or social factors, conflicts of interest, or other reasons that make the investigator/participating physician inappropriate as a subject for this clinical trial

Related Information

• Primary Sponsor: Omori Kazuhiro
• Source(s) of Monetary Support: SUN MEDICAL CO., LTD.,Japan Agency for Medical Research and Development (AMED)