Clinical trial · Interventional
Effects of Mucoprotective Product on Xerostomia
Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients
NCT01316393CI-TRIAL-00005753completedPhase 4ClinicalTrials.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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XER2020 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- XER2020
- description
- mucoprotective product
- interventionNames
- Other: XER2020
- type
- ACTIVE_COMPARATOR
- label
- Saliva Natura
- description
- salivary substitute
- interventionNames
- Other: XER2020
- type
- PLACEBO_COMPARATOR
- label
- XER2020 placebo
- interventionNames
- Other: XER2020
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient must be at least 18 years of age. 2. The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer 3. The patient must understand and consent in writing to the procedure. Exclusion Criteria: 1. Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values. 2. 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 3. Patients who are unable or unwilling to cooperate with study procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.