Status:
COMPLETED
Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial
Lead Sponsor:
Universiti Kebangsaan Malaysia Medical Centre
Conditions:
Xerostomia, Hyposalivation, Saliva Substitute, Radiation-induced Toxicity, Nasopharyngeal Cancer
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief Summary
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 (R...
Detailed Description
Xerostomia, or dry mouth caused by reduced or absent saliva flow, is a subjective symptom that can lead to impaired chewing, swallowing, altered sense of taste and speech. This eventually affects thei...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04491435
Start Date
June 5 2018
End Date
March 5 2020
Last Update
July 29 2020
Active Locations (1)
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1
Universiti Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000