Xerostomia, Hyposalivation, Saliva Substitute, Radiation-induced Toxicity, Nasopharyngeal Cancer Clinical Trial
Official title:
Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial
NCT number | NCT04491435 |
Other study ID # | FF2018-133 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2018 |
Est. completion date | March 5, 2020 |
Verified date | July 2020 |
Source | Universiti Kebangsaan Malaysia Medical Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | March 5, 2020 |
Est. primary completion date | January 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
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 Sj?gren syndrome. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Universiti Kebangsaan Malaysia Medical Centre | Cheras | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
Universiti Kebangsaan Malaysia Medical Centre |
Malaysia,
Gravenmade EJ, Vissink A. Mucin-containing lozenges in the treatment of intraoral problems associated with Sjögren's syndrome. A double-blind crossover study in 42 patients. Oral Surg Oral Med Oral Pathol. 1993 Apr;75(4):466-71. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | summated xerostomia inventory (SXI) score | summated xerostomia inventory (SXI) score at baseline-summated xerostomia inventory (SXI) score at 4 weeks post intervention | 4 weeks | |
Secondary | unstimulated whole saliva (UWS) flow | unstimulated whole saliva (UWS) flow at 4 weeks post intervention -unstimulated whole saliva (UWS) flow at baseline | 4 weeks |