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Oral Mucositis Management in Patients Receiving Radiation for Head and Neck Cancer: An Evaluation of a Barrier Based Treatment (TOPHAT)

2026年7月8日 更新者：McMaster University

A Prospective Feasibility Cohort Trial of Oral Mucositis Management in Patients Receiving Radiation for Head and Neck Cancer: An Evaluation of a Barrier-based Treatment (Gelclair)

Patients who are undergoing radiation therapy on their head and/or neck, are highly likely to experience oral mucositis, which is inflammation and irritation of the mucus membranes in your mouth. This inflammation leads to difficulty eating and drinking normally as it becomes painful to do so. Currently, the Juravinski Cancer Centre (JCC) uses a standard mouth rinse to try and help prevent inflammation/soothe the pain of inflammation caused by radiation treatments, however, better options may exist. Biosyent's Gelclair is a widely available, safe-to-use mouth rinse that aims to create a protective coating on your mucus membranes to help reduce inflammation and discomfort during your radiation treatment. We aim to see if this product provides a more positive experience for patients then the current mouth rinse utilized by the JCC.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

The current magic mouthwash being utilized at the JCC for standard of care for Heck and Neck Radiation patients has been shown to not be anymore effective than other standard sulcate-tantum mouthwashes in preventing discomfort or reducing the requirement of needing a feeding tube for sustenance during radiation treatments. More recently two mucoadhesive topical coating agents have been approved in Canada for this population of patients, Gengigel and Gelclair. These agents adhere to the mucosa and potentially improve efficacy of the therapeutic agent due to rapid absorption and easy application. A recent systematic review of bioadhesives for the treatment of RIOM found statistically significant decrease in severe oral mucositis. We aim to determine if patients tolerate gelclair use, and to determine their use of and satisfaction with gelclair. This will inform the need for a large national RCT on Gelclair use.

研究类型

介入性

注册 (实际的)

29

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Ontario
      • Hamilton、Ontario、加拿大、L8V 5C2
        • Juravinski Cancer Centre

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 18 years of age or older.
  • Histologically proven (from either the primary lesion or regional lymph nodes) squamous cell carcinoma of the oropharynx or oral cavity.
  • Plan to receive at least 60 Gy dose of radiotherapy to be delivered daily Monday to Friday for 6 to 7 weeks.

Exclusion Criteria:

  • Patient is unable (i.e. insufficiently fluent) or unwilling to complete the weekly questionnaires which are written in English.
  • Inability to provide informed consent.
  • ECOG performance score 2 or better.
  • Plan to receive a concurrent chemotherapy agent other than cisplatin.
  • Investigational agent of any kind within 30 days prior to enrollment.
  • Concurrent administration of any other experimental intervention given for the purpose of preventing RIOM (see section 7.5).
  • History of allergies or hypersensitivity reactions to any of the components in Gelclair.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：设备可行性
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment Group: Gelclair
Treatment Group: Patients who receive Gelclair as part of their participation in the study
设备：Gelclair Oral Mouth Rinse
Gelclair is viscous gel that is designed to sooth pain relating to oral mucositis.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility of Recruitment:
大体时间：6 Months

Feasibility based on:

Recruitment Rate (Pass is successful recruitment of 40 patients within 6 months)
6 Months
Participant Compliance Rate
大体时间：8 weeks
• Compliance Rate (Percent of patient who complete study & all questionnaires as per protocol, pass is >75%)
8 weeks
Product Tolerability Rate
大体时间：8 Weeks
• Tolerability Rate (Percent of patients who use Gelclair for 10 days or longer, pass is >50%)
8 Weeks

次要结果测量

结果测量
措施说明
大体时间
Time to Grade 3 Oral Mucositis
大体时间：8 Weeks
Time from enrollment (day 0 of RT) until grade 3 oral mucositis (measured in days) is reported.
8 Weeks
Patient Reported QoL
大体时间：8 Weeks
The severity of patient-reported symptoms of oral mucositis throughout the course of treatment as determined by clinically significant change in Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN; see Appendix II questions 1-8) scores from baseline. The OMWQ-HN will be administered before the start of RT at baseline, and every 2 weeks until completion of RT, therefore weeks 2, 4, and 6 and then 1 final time 2 weeks post-treatment on week 8.
8 Weeks
Ability to Eat
大体时间：8 Weeks
Number of days from start of treatment to feeding tube insertion / % participants requiring feeding tubes
8 Weeks
Time to the Initiation of Systemic Opiods
大体时间：8 Weeks
Time from enrollment (day 0 of RT) until the initiation of potent systemic opioid or increase in dose from baseline (measured in days).
8 Weeks
Radiation Therapy Delay >7 Days
大体时间：8 Weeks
Time from enrollment (day 0 of RT) until treatment delay of RT of 7 days or longer.
8 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

McMaster University

合作者

Hamilton Health Sciences Corporation
Escarpment Cancer Research Institute (ECRI)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月15日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2025年8月28日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 18414

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

This is a small scale feasibility trial that will inform if a larger, more impact trial is warranted. To protect patient privacy and confidentiality, IDE will not be shared outside of the study team.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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