Clinical trial · Interventional
A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer
Long-term Evaluation of the Effectiveness Of a Novel Intra-oral Electro-stimulator for the Treatment of raDiotherapy-ASsociated Dry Mouth
NCT02941276CI-TRIAL-00054847LEONIDAS-2completedN/AClinicalTrials.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)
This trial is looking at using an intra-oral electrostimulating device for the management of radiotherapy-induced dry mouth.
Conditions
Conditions (2)
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Electrostimulator device | Device | — | UNRESOLVED |
| Sham Electrostimulator device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Active electrostimulator device (intra-oral active second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)
- interventionNames
- Device: Active Electrostimulator device
- type
- SHAM_COMPARATOR
- label
- Group B
- description
- Sham electrostimulator device (intra-oral sham second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)
- interventionNames
- Device: Sham Electrostimulator device
Primary outcomes (1)
- measure
- Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. To be at least 18 years old 2. To have received more than 40 Gy of external beam RT for cancer in the H\&N region at least 4 months before entry into the study 3. To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema 4. To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm VAS scale (0=no dryness; 100 =maximum dryness). 5. To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax) 6. To have at least one parotid gland Exclusion Criteria: 1. To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V) 2. To have known allergy to materials similar to those used in the investigational product 3. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids 4. To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes). 5. To use of pilocarpine as systemic therapy 6. To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min) 7. To have no parotid glands
References
Publications (0)
Data not yet available
No reference posted for this study.