Faculty of Dental Medicine and Oral Health Sciences, McGill University, Montreal, Quebec, Canada
Faculty of Dental Medicine and Oral Health Sciences, McGill University, Montreal, Quebec, Canada.
BMJ Open. 2023 Jul 27;13(7):e074498. doi: 10.1136/bmjopen-2023-074498.
Head and neck cancers (HNCs) are a significant health burden worldwide. Oral human papillomavirus (HPV) infection is a major risk factor for HNCs. Unfortunately, currently available prophylactic vaccines have limited coverage and potential for HPV type replacement. Carrageenan, a natural product extracted from marine red algae, has demonstrated potency as an HPV inhibitor and could offer a potential alternative to prevent HPV-related diseases, including oral HPV infection. However, there is a lack of clinical studies on the effect of carrageenan on oral HPV infections. As a first step to address this gap, we propose a randomised controlled trial (RCT) to evaluate the feasibility of conducting a larger multicentric RCT to investigate the effect of a carrageenan mouthwash on oral HPV infection.
We will conduct a placebo-controlled triple-blinded feasibility RCT with two parallel arms, each arm consisting of 20 participants. Participants will complete a single in-person visit at baseline and conduct biweekly follow-ups from home by completing a web-based questionnaire and sending saliva self-samples via mail. During the 6-month period trial, participants will gargle with the mouthwash morning and night, and around sexual activities. The study will evaluate several factors including recruitment and retention rates, the feasibility of data collection procedures, compliance with study procedures, acceptability of RCT procedures and intervention and safety data on carrageenan use in the oral cavity. We will estimate the standard deviation of outcome measures, including time to the incidence of oral HPV infection and time to clearance of prevalent oral HPV infection. The trial primary outcome is whether to proceed to a definitive trial based on prespecified progression criteria.
The protocol was approved by the McGill University institutional review board. Study results will be presented at scientific conferences and published in academic journals.
NCT05746988.
头颈部癌症（HNC）是全球范围内的一个重大健康负担。口腔人乳头瘤病毒（HPV）感染是 HNC 的一个主要危险因素。不幸的是，目前可用的预防性疫苗覆盖范围有限，并且存在 HPV 型别替代的潜在风险。角叉菜胶是一种从海洋红藻中提取的天然产物，已被证明具有抑制 HPV 的效力，并且可能成为预防 HPV 相关疾病（包括口腔 HPV 感染）的潜在替代方法。然而，目前缺乏关于角叉菜胶对口腔 HPV 感染影响的临床研究。作为解决这一差距的第一步，我们提出了一项随机对照试验（RCT），以评估开展更大规模多中心 RCT 的可行性，以研究角叉菜胶漱口水对口腔 HPV 感染的影响。
我们将进行一项安慰剂对照的三盲可行性 RCT，分为两个平行组，每组 20 名参与者。参与者将在基线时完成一次面对面就诊，并在家中通过完成在线问卷和通过邮件发送唾液自检样本进行两周一次的随访。在 6 个月的试验期间，参与者将早晚用漱口水漱口，并在性行为前后使用。该研究将评估包括招募和保留率、数据收集程序的可行性、研究程序的依从性、RCT 程序的可接受性以及口腔中使用角叉菜胶的安全性和效果数据在内的几个因素。我们将估计结局测量的标准偏差，包括口腔 HPV 感染的发生时间和现有口腔 HPV 感染的清除时间。该试验的主要结局是根据预设的进展标准确定是否进行确定性试验。
该方案已获得麦吉尔大学机构审查委员会的批准。研究结果将在科学会议上进行报告，并发表在学术期刊上。
NCT05746988。
