- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02687087
A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy
Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lanarkshire
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Glasgow, Lanarkshire, United Kingdom, G12 0YN
- Beatson West of Scotland Cancer Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Visco-ease
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.
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19.6 mg/mL of LMS-611
Other Names:
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Placebo Comparator: RIX-Placebo
Physiological Saline (sodium chloride 0.9% (w/v)
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Physiological Saline
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in GRIX Score
Time Frame: From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment)
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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.
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From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claire Paterson, Beatson West of Scotland Cancer Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN14ON413
- 00908 (Other Identifier: Funder)
- 44528835 (Registry Identifier: ISRCTN Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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