{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T18:07:38Z","timestamp":1780596458294,"version":"3.54.1"},"reference-count":12,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T00:00:00Z","timestamp":1780531200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP25ck0106033"],"award-info":[{"award-number":["JP25ck0106033"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:p>Oral mucositis is a frequent and debilitating adverse event observed in patients undergoing chemotherapy or radiotherapy. Current management strategies are limited in duration, require frequent application, and fail to address the mechanical irritation from teeth. A novel device, Soft Protector CPC, was developed to overcome these limitations. This multicenter, randomized, two-arm, open-label, confirmatory trial aims to evaluate the efficacy and safety of Soft Protector CPC in patients with breast cancer undergoing chemotherapy. A total of 154 participants will be randomly assigned in a 1:1 ratio to receive either oral care with Soft Protector CPC or oral care alone. The primary endpoint will be oral mucositis as assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 during the comparative treatment period. The secondary endpoints will include CTCAE v3.0 during the continuous treatment period, oral mucositis, pain (CTCAE v5.0), quality of life (Patient Reported Outcomes-CTCAE version 1.0 [PRO-CTCAE v1.0], the 15-item oral health questionnaire of the European Organization For Research And Treatment Of Cancer [EORTC QLQ-OH15], and the pain Numeric Rating Scale), onset and site of mucositis, completion of chemotherapy, use of rescue medications, technical feasibility, and patient preference. The safety endpoints will include adverse events, device malfunction, and laboratory tests. This trial is expected to establish the clinical utility of the Soft Protector CPC for the prevention and management of oral mucositis, with the potential to improve the patients\u2019 quality of life and adherence to cancer therapy. This study was approved by the Clinical Research Review Board and registered with the Japan Registry of Clinical Trials, jRCTs062250005, on April 18, 2025.<\/jats:p>","DOI":"10.1371\/journal.pone.0350803","type":"journal-article","created":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T17:26:43Z","timestamp":1780594003000},"page":"e0350803","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["A multicenter, randomized, parallel-group confirmatory study protocol to evaluate the efficacy of Soft Protector CPC, a novel oral mucosal protectant, in preventing oral mucositis and alleviating pain in patients with breast cancer"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4129-1401","authenticated-orcid":true,"given":"Kazuhiro","family":"Omori","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kohei","family":"Furukawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masatoshi","family":"Usubuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomofumi","family":"Hamada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadahiko","family":"Shien","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michihiro","family":"Yoshida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2054-7483","authenticated-orcid":true,"given":"Yuki","family":"Nakatsuka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0112-0843","authenticated-orcid":true,"given":"Katsuyuki","family":"Hotta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2897-1231","authenticated-orcid":true,"given":"Soichiro","family":"Ibaragi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4712-6829","authenticated-orcid":true,"given":"Shogo","family":"Takashiba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,6,4]]},"reference":[{"issue":"1","key":"pone.0350803.ref001","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1038\/s41368-025-00382-8","article-title":"Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis","volume":"17","author":"J Xia","year":"2025","journal-title":"Int J Oral Sci"},{"issue":"22","key":"pone.0350803.ref002","doi-asserted-by":"crossref","first-page":"16314","DOI":"10.3390\/ijms242216314","article-title":"The role of the innate immune response in oral mucositis pathogenesis","volume":"24","author":"J Bowen","year":"2023","journal-title":"Int J Mol Sci"},{"issue":"9","key":"pone.0350803.ref003","doi-asserted-by":"crossref","first-page":"1","DOI":"10.12968\/hmed.2022.0324","article-title":"Treatment-induced mucositis in oncology","volume":"83","author":"F Jasiewicz","year":"2022","journal-title":"Br J Hosp Med (Lond)"},{"key":"pone.0350803.ref004","doi-asserted-by":"crossref","first-page":"3497","DOI":"10.2147\/JMDH.S467455","article-title":"The effect of oral care intervention in mucositis management among pediatric cancer patients: an updated systematic review","volume":"17","author":"I Nurhidayah","year":"2024","journal-title":"J Multidiscip Healthc"},{"issue":"6","key":"pone.0350803.ref005","doi-asserted-by":"crossref","first-page":"368","DOI":"10.61872\/sdj-2023-06-962","article-title":"Clinical guidance for maintaining oral hygiene in patients undergoing chemotherapy or radiation therapy: a scoping review","volume":"133","author":"J Chan","year":"2023","journal-title":"Swiss Dent J"},{"issue":"1","key":"pone.0350803.ref006","doi-asserted-by":"crossref","first-page":"967","DOI":"10.3390\/curroncol30010074","article-title":"Interventions for the prevention of oral mucositis in patients receiving cancer treatment: evidence from randomised controlled trials","volume":"30","author":"G Colella","year":"2023","journal-title":"Curr Oncol"},{"key":"pone.0350803.ref007","unstructured":"European Oral Care in Cancer Group EOCC. Oral care guidance. 1st Japanese ed. ed. Japanese Association of Supportive Care in Cancer Mucositis Subcommittee."},{"key":"pone.0350803.ref008","unstructured":"Multinational Association of Supportive Care in Cancer (MASCC)\/International Society of Oral Oncology (ISOO). Evidence-based clinical practice guidelines for mucosal injury associated with cancer treatment. MASCC\/ISOO Mucositis Study Group; 2014."},{"issue":"11","key":"pone.0350803.ref009","doi-asserted-by":"crossref","first-page":"1337","DOI":"10.1093\/aje\/kwm223","article-title":"A modified least-squares regression approach to the estimation of risk difference","volume":"166","author":"YB Cheung","year":"2007","journal-title":"Am J Epidemiol"},{"issue":"2","key":"pone.0350803.ref010","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1016\/S1368-8375(02)00033-7","article-title":"Risk factors for ulcerative oral mucositis in cancer patients: unanswered questions","volume":"39","author":"A Barasch","year":"2003","journal-title":"Oral Oncol"},{"issue":"1","key":"pone.0350803.ref011","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1634\/theoncologist.2011-0111","article-title":"Oral adverse events associated with tyrosine kinase and mammalian target of rapamycin inhibitors in renal cell carcinoma: a structured literature review","volume":"17","author":"CB Boers-Doets","year":"2012","journal-title":"Oncologist"},{"key":"pone.0350803.ref012","doi-asserted-by":"crossref","first-page":"102720","DOI":"10.1016\/j.ctrv.2024.102720","article-title":"Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan","volume":"125","author":"RS Heist","year":"2024","journal-title":"Cancer Treat Rev"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0350803","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T17:26:48Z","timestamp":1780594008000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0350803"}},"subtitle":[],"editor":[{"given":"Yu","family":"Uneno","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,6,4]]},"references-count":12,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2026,6,4]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0350803","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,4]]}}}