N/A
N=129
Blinded Dry Mouth Spray Crossover Study
Xerostomia · Head and Neck Cancer · Xerostomia Following Radiotherapy
Bottom Line
View on ClinicalTrials.gov: NCT04608773 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Oral Dryness — 45.5; 46.6; 52.76; 54.1 units on a scale — p=<0.501
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remineralizing Extreme Dry Mouth Spray with Xylitol (Other); Alcohol-Free Moisturizing Dry Mouth Spray (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jonas Johnson
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oral Dryness |
45.5; 46.6; 52.76; 54.1 | <0.501 |
| SECONDARY Sleeping Difficulty Due to Oral Dryness |
56.3; 61.9; 66.8; 64.8 | .109 |
| SECONDARY Speaking Difficulty Due to Oral Dryness |
60.8; 63.0; 69.9; 66.8 | .107 |
| SECONDARY Taste Alteration/Impairment Due to Oral Dryness |
73.2; 71.5; 78.1; 75.4 | .489 |
| SECONDARY Swallowing and Chewing Difficulty Due to Oral Dryness |
53.7; 54.6; 62.7; 60.4 | .213 |
| SECONDARY Saliva PH |
5.3; 5.5; 5.4; 5.5 | .486 |
| SECONDARY Difficulty Wearing Dental Prostheses (if Applicable) |
— | — |
Summary
To identify the effectiveness of two mouth sprays at relieving symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.
To assess patient quality of life and mouth acidity following use of two mouth sprays meant to relieve symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.
Eligibility Criteria
Inclusion Criteria
- biopsy-proven oral cavity, oropharynx, larynx, and hypopharynx carcinoma
- who received primary radiation with curative intent (>50 Gray in 20 fractions)
- radiation treatment completed greater than 6 months ago
- who endorse xerostomia
Exclusion Criteria
- evidence of metastasis or recurrent disease
- Current use of pilocarpine, antidepressants, anticholinergic drugs, or any other medication that has an effect on salivation
- those who have documented medical conditions associated with xerostomia such as Sjogren's Syndrome
- those who use oral inhalants for the treatment of respiratory disease
Data sourced from ClinicalTrials.gov (NCT04608773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.