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)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment Group: Gelclair
Treatment Group: Patients who receive Gelclair as part of their participation in the study
干预措施: Gelclair Oral Mouth Rinse (Device)
结局指标
主要结局
Feasibility of Recruitment:
时间窗: 6 Months
Feasibility based on: Recruitment Rate (Pass is successful recruitment of 40 patients within 6 months)
Participant Compliance Rate
时间窗: 8 weeks
• Compliance Rate (Percent of patient who complete study \& all questionnaires as per protocol, pass is \>75%)
Product Tolerability Rate
时间窗: 8 Weeks
• Tolerability Rate (Percent of patients who use Gelclair for 10 days or longer, pass is \>50%)
次要结局
- Time to Grade 3 Oral Mucositis(8 Weeks)
- Patient Reported QoL(8 Weeks)
- Ability to Eat(8 Weeks)
- Time to the Initiation of Systemic Opiods(8 Weeks)
- Radiation Therapy Delay >7 Days(8 Weeks)