Exploratory study to investigate the efficacy and safety of a novel oral mucosa protective material (development code:726X8-2) in patients with cancer chemotherapy-induced oral mucositis

Omori Kazuhiro0 sites30 target enrollmentJanuary 19, 2023

Overview

No summary available.

Registry

who.int

Start Date

January 19, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Omori Kazuhiro

•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

•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