NCT04491435

Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Universiti Kebangsaan Malaysia Medical Centre · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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 (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.

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 their nutritional status and quality of life. The reported prevalence of xerostomia in NPC survivors ranged from 80% -100% \[6-9\]. This high prevalence has stemmed a lot of interest in prevention and treatment of this important sequelae. Saliva substitute in the forms of gels, toothpaste, sprays or mouthwash has been used for treatment of xerostomia \[10\]. Oral7® mouthwash (Oral7 International, United Kingdom) is a mucin-based saliva substitute formulated with natural enzymes such as lactoperoxidase, lysozyme, glucose oxidase and lactoferrin, similar to naturally occuring saliva. The biophysical properties of the mouthwash can potentially provide relief to xerostomia symptoms in patients post radiotherapy translating to a better quality of life. Hence, the purpose of the present study is to evaluate the effects of saliva substitute in treating xerostomia among NPC patients post radiotherapy. The primary end-point of the study was to compare the subjective xerostomia symptoms, measured using a validated inventory taken 4 weeks following intervention and at baseline between patients who did not receive and patients who received Oral7® mouthwash. The secondary end-point was to demonstrate similar changes in objective measurements using sialometry techniques.

Conditions

• Xerostomia, Hyposalivation, Saliva Substitute, Radiation-induced Toxicity, Nasopharyngeal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Summated Xerostomia Inventory	structured interview by a dedicated researcher to obtain a score of the summated xerostomia inventory (SXI)
DIAGNOSTIC_TEST	Sialometry	unstimulated whole saliva (UWS) flow measurement

Timeline

• Start date: 2018-06-05
• Primary completion: 2020-01-05
• Completion: 2020-03-05
• First posted: 2020-07-29
• Last updated: 2020-07-29

Locations

1 site across 1 country: Malaysia