Clinical trial · Interventional
Blinded Dry Mouth Spray Crossover Study
Evaluation of Two Mouth Sprays for Post-irradiation Xerostomia in Head and Neck Cancer Survivors: a Randomized, Double-blind Clinical Trial
NCT04608773CI-TRIAL-00073514completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Xerostomia | — | UNRESOLVED | — |
| Xerostomia Following Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alcohol-Free Moisturizing Dry Mouth Spray | Device | — | UNRESOLVED |
| Remineralizing Extreme Dry Mouth Spray with Xylitol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Biotene Spray, followed by Refresh Spray
- description
- The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)
- interventionNames
- Other: Remineralizing Extreme Dry Mouth Spray with Xylitol
- Device: Alcohol-Free Moisturizing Dry Mouth Spray
- type
- OTHER
- label
- Refresh Spray, followed by Biotene Spray
- description
- The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)
- interventionNames
- Other: Remineralizing Extreme Dry Mouth Spray with Xylitol
- Device: Alcohol-Free Moisturizing Dry Mouth Spray
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDEpstein JB, Emerton S, Le ND, Stevenson-Moore P. A double-blind crossover trial of Oral Balance gel and Biotene toothpaste versus placebo in patients with xerostomia following radiation therapy. Oral Oncol. 1999 Mar;35(2):132-7. doi: 10.1016/s1368-8375(98)00109-2. PMID 10435146
- BACKGROUNDWarde P, Kroll B, O'Sullivan B, Aslanidis J, Tew-George E, Waldron J, Maxymiw W, Liu FF, Payne D, Cummings B. A phase II study of Biotene in the treatment of postradiation xerostomia in patients with head and neck cancer. Support Care Cancer. 2000 May;8(3):203-8. doi: 10.1007/s005200050286. PMID 10789961
- BACKGROUNDEisbruch A, Rhodus N, Rosenthal D, Murphy B, Rasch C, Sonis S, Scarantino C, Brizel D. How should we measure and report radiotherapy-induced xerostomia? Semin Radiat Oncol. 2003 Jul;13(3):226-34. doi: 10.1016/S1053-4296(03)00033-X. PMID 12903012