A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck cancer patients. A parallel group double blind study design has been selected. The primary outcome is change in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome will be compared between Visco-ease and the placebo treatment.

Official Title
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Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients

Conditions
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Xerostomia

Intervention / Treatment
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* Device: Visco-ease
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided written informed consent Male or female subjects ≥ 18 years of age Subjects prescribed radiotherapy or chemoradiotherapy as primary treatment for head and neck tumours where one or more parotid glands will receive a significant dose of radiation as judged by the CI or PI during the radiotherapy planning process Exclusion Criteria: Subject is pregnant or breastfeeding Subjects with known allergies to egg, soya, or lanolin (sheep's wool grease) based products Subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. Sjögren's syndrome) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure Subjects who have participated in an investigational medicinal product study within 30 days prior to signing consent Any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (at the discretion of the CI or PI) Subjects who are unable to independently complete the questionnaire or diary Subjects who are judged inappropriate for inclusion in the study by the CI or PI Subjects with head and neck cancer who have had surgery to the primary site. Neck dissection alone is not an exclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visco-ease<br>Visco-ease is a suspension of multilamellar vesicles comprising lipids in ratios which mimic the lipidic composition of endogenous extra-alveolar lamellar bodies. Visco-ease is suspended in physiological saline (0.9% NaCl) to provide a final dose concentration of 19.6 mg/mL. Visco-ease is a white to off-white turbid suspension. The device under evaluation in this clinical investigation is Visco-ease at a concentration of 19.6 mg/mL. | Device: Visco-ease<br>* 19.6 mg/mL of LMS-611<br>* Other names: LMS-611;|
| Placebo Comparator: RIX-Placebo<br>Physiological Saline (sodium chloride 0.9% (w/v) | Device: Placebo<br>* Physiological Saline<br>* Other names: 0.9% (w/v) Physiological Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GRIX Score | The primary endpoint will compare change in GRIX scores from baseline to 6-week follow-up between the group treated with Visco-ease and the Placebo group. | From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy Induced Xerostomia (RIX)