Randomized investigator-blinded crossover study of the efficacy of XyliMelts adhesive tablets for symptomatic relief of nocturnal dry mouth in patients with dry mouth after head and neck irradiatio
Not Applicable
Recruiting
- Conditions
- K11.7Z92.3Disturbances of salivary secretionPersonal history of irradiation
- Registration Number
- DRKS00030537
- Lead Sponsor
- Quest Products, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Minimum age: 18
- Ability to consent to study participation.
- Written informed consent
- Patients from the dental group practice of Dr. Dirheimer and Dr. Ludwig Ulm, Germany.
- Subjective xerostomia: at least 6 on a VAS scale of 1 to 10 after waking AND at least 6 weeks of radiation therapy due to tumor disease in the head and neck region
- Primary therapy at least 6 months, maximum 18 months ago
Exclusion Criteria
- Existing or planned pregnancy during the study
- Current radiotherapy/chemotherapy or antibody therapy
- Acute inflammatory oral disease/abscess
- Change in medication with possible influence on salivary flow rates during the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate whether the use of Xylimelts adhesive tablets during the night induces subjective symptom relief (VAS 100mm) in patients with nocturnal dry mouth after irradiation in the head and neck region in a before-after comparison and in a comparison with the use of water.
- Secondary Outcome Measures
Name Time Method To investigate whether the use of Xylimelts adhesive tablets during the night brings about an improvement with regard to the following study parameters in a before-after comparison as well as in comparison with the use of water:<br>- 100 mm VAS Dry Mouth Scale. <br>- Shahdad Questionnaire of symptomatic relief <br>- Number of nocturnal awakenings<br>- Objective test of saliva volume (modified umbrella test and WSS/UWSS)<br>Documentation of side effects, adverse events, or (not expected) serious adverse events.