Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial
Condition: Xerostomia, Hyposalivation, Saliva Substitute, Radiation-induced Toxicity, Nasopharyngeal Cancer
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Xerostomia
Study type: Interventional

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.
    

Intervention name(s): Summated Xerostomia Inventory; Sialometry
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): structured interview by a dedicated researcher to obtain a score of the summated xerostomia inventory (SXI); unstimulated whole saliva (UWS) flow measurement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care