Hypopharyngeal Cancer, Nasopharyngeal Cancer, Oropharyngeal Cancers, Squamous Cell Carcinoma
Conditions
Keywords
Radiation Therapy, Squamous Cell Carcinoma, Oral Cancer, Neck Cancer, Quality of Life (QoL)
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGelclair Oral Mouth Rinse
Gelclair is viscous gel that is designed to sooth pain relating to oral mucositis.
Sponsors
McMaster University
Hamilton Health Sciences Corporation
Escarpment Cancer Research Institute (ECRI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Cohort of Eligible Patients (Consecutive Recruitment)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment: | 6 Months | Feasibility based on: Recruitment Rate (Pass is successful recruitment of 40 patients within 6 months) |
| Participant Compliance Rate | 8 weeks | • Compliance Rate (Percent of patient who complete study \& all questionnaires as per protocol, pass is \>75%) |
| Product Tolerability Rate | 8 Weeks | • Tolerability Rate (Percent of patients who use Gelclair for 10 days or longer, pass is \>50%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Grade 3 Oral Mucositis | 8 Weeks | Time from enrollment (day 0 of RT) until grade 3 oral mucositis (measured in days) is reported. |
| Patient Reported QoL | 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. |
| Ability to Eat | 8 Weeks | Number of days from start of treatment to feeding tube insertion / % participants requiring feeding tubes |
| Time to the Initiation of Systemic Opiods | 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). |
| Radiation Therapy Delay >7 Days | 8 Weeks | Time from enrollment (day 0 of RT) until treatment delay of RT of 7 days or longer. |
Countries
Canada
Outcome results
None listed