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

Phase 2

Recruiting

• Conditions: Oral mucositis; Mucous membrane disorder; K123

• Registration Number: JPRN-jRCTs062220084
• Lead Sponsor: Omori Kazuhiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Grade of oral mucositis, oral pain, etc.<br>(Grade evaluation based on CTCAE v5.0/MedDRA/J v25.1)<br><br>2) Sub-Criteria for Oral Mucositis according to CTCAE v3.0<br><br>3) PRO-CTCAE v1.0 [Patient Evaluation].

Secondary Outcome Measures

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