A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients|
- Change in GRIX Score [ Time Frame: From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment) ]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.
|Actual Study Start Date:||March 24, 2016|
|Study Completion Date:||February 2, 2017|
|Primary Completion Date:||February 2, 2017 (Final data collection date for primary outcome measure)|
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.
19.6 mg/mL of LMS-611
Placebo Comparator: RIX-Placebo
Physiological Saline (sodium chloride 0.9% (w/v)
Other Name: 0.9% (w/v) Physiological Saline
Please refer to this study by its ClinicalTrials.gov identifier: NCT02687087
|Beatson West of Scotland Cancer Centre|
|Glasgow, Lanarkshire, United Kingdom, G12 0YN|
|Principal Investigator:||Claire Paterson||Beatson West of Scotland Cancer Centre|