Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061695) titled 'Effect of Ozone Nanobubble Water on Chemotherapy-Induced Oral Mucositis' on June 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - colorectal or gastric cancer receiving chemotherapy regimens including FOLFOX or XELOX. Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To compare the incidence and severity of chemotherapy-induced oral mucositis and quality of life (QOL) in patients with gastrointestinal cancers undergoing chemotherapy, between those receiving oral rinsing with ozonated nanobubble water and those receiving standard oral care. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will perform oral rinsing with ozone nano-bubble water three times daily after tooth brushing during the first cycle of chemotherapy.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Participants who meet all of the following criteria will be eligible for inclusion:

1.Patients with colorectal or gastric cancer scheduled to receive chemotherapy regimens including FOLFOX or XELOX 2.Patients who are able to safely perform oral rinsing without choking or aspiration 3.Patients aged 20 years or older at the time of informed consent 4.Patients who have provided written informed consent after receiving adequate explanation using an informed consent document Key exclusion criteria - Patients meeting any of the following criteria will be excluded:

1.Patients who are unable to safely and appropriately perform oral rinsing due to swallowing disorders, impaired consciousness, or cognitive impairment 2.Patients with a history of hypersensitivity to any component of ozonated nanobubble water 3.Patients judged by the principal investigator to be inappropriate for participation in this study for safety reasons Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 29 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2027 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070593

Disclaimer: Curated by HT Syndication.