Clinical trial · Interventional
Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial
- 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)
Nasopharyngeal carcinoma (NPC) is the highest reported otorhinolaryngological malignancy reported in Malaysia affecting predominantly male adults between 40-60 years old \[1, 2\]. Radiation therapy (RT) has been coined as the mainstay treatment owing to its' radiosensitive properties \[1, 3\]. Radiation-induced DNA damage impairs proper cell division, resulting in cell death or senescence of cells that attempt to divide, particularly useful in killing malignant cells. However, radiation doses to the salivary glands cause loss of saliva producing acinar cells which ultimately hampers production of saliva in NPC patients post radiation \[4\]. This leads to progressive loss of salivary gland function causing xerostomia symptoms \[5\]. This study aims to compare the effects of two mouthwashes in the treatment of 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, Hyposalivation, Saliva Substitute, Radiation-induced Toxicity, Nasopharyngeal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sialometry | Diagnostic Test | — | UNRESOLVED |
| Summated Xerostomia Inventory | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- 4 weeks use of mucin-based saliva substitute
- interventionNames
- Diagnostic Test: Summated Xerostomia Inventory
- Diagnostic Test: Sialometry
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- 4 weeks use of xylitol-based mouthwash
- interventionNames
- Diagnostic Test: Summated Xerostomia Inventory
- Diagnostic Test: Sialometry
Primary outcomes (1)
- measure
- summated xerostomia inventory (SXI) score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have completed radiation therapy or concurrent chemotherapy and radiation therapy for nasopharyngeal carcinoma (clinical staging of tumour based on AJCC staging (8th edition) T1-4, N0-3, M0). * Patients age 20 years old to 85 years old. * Two months has elapsed since last dose of chemotherapy or radiotherapy * Karnofsky performance score more than 70%. * Patients complaining of xerostomia. Exclusion Criteria: * Those contraindicated to using mouthwash (established allergy to lactoperoxidase, lysozyme, glucose oxidase lactoferrin, cetylpyridinium chloride and xylitol) * Patients with residual or recurrent disease. * Patients who received intensity modulated radiation therapy. * Patients with ongoing oral mucositis (WHO Oral Mucositis grading I to IV) * Patients with facial, glossopharyngeal. vagus and hypoglossal nerve palsy/ paresis. * Patients who had any form of concurrent treatment protocols (hormonal, alternative, antiviral, sialogogues or photodynamic therapy) during the study duration. * Patients with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis and Sjớgren syndrome.
References
Publications (2)
- BACKGROUNDGravenmade EJ, Vissink A. Mucin-containing lozenges in the treatment of intraoral problems associated with Sjogren's syndrome. A double-blind crossover study in 42 patients. Oral Surg Oral Med Oral Pathol. 1993 Apr;75(4):466-71. doi: 10.1016/0030-4220(93)90172-z. PMID 8464611
- DERIVEDMarimuthu D, Han KM, Mohamad MSF, Azman M. Saliva substitute mouthwash in nasopharyngeal cancer survivors with xerostomia: a randomized controlled trial. Clin Oral Investig. 2021 May;25(5):3105-3115. doi: 10.1007/s00784-020-03634-5. Epub 2020 Nov 11. PMID 33175253