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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
44
19.6 mg/mL of LMS-611
Physiological Saline
Beatson West of Scotland Cancer Centre
Glasgow, Lanarkshire, United Kingdom
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.
Time frame: From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment)
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