Effects of Mucoprotective Product on Xerostomia
Phase 4
Completed
- Conditions
- Xerostomia
- Interventions
- Other: XER2020
- Registration Number
- NCT01316393
- Lead Sponsor
- Camurus AB
- Brief Summary
In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- The patient must be at least 18 years of age.
- The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
- The patient must understand and consent in writing to the procedure.
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Exclusion Criteria
- Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
- Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
- Patients who are unable or unwilling to cooperate with study procedures.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description XER2020 XER2020 mucoprotective product XER2020 placebo XER2020 - Saliva Natura XER2020 salivary substitute
- Primary Outcome Measures
Name Time Method OHIP questionaire health impact profile 7 days Effect on oral health quality will be assessed after each treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Prosthetic Dentistry, Malmö University
🇸🇪Malmö, Sweden