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

NCT04491435 | Completed

• 1 other identifier: FF2018-133
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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 (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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• unstimulated whole saliva (UWS) flow

  4 weeks

Study Arms (2)

Interventional

EXPERIMENTAL

4 weeks use of mucin-based saliva substitute

Diagnostic Test: Summated Xerostomia Inventory; Diagnostic Test: Sialometry

Control

PLACEBO COMPARATOR

4 weeks use of xylitol-based mouthwash

Diagnostic Test: Summated Xerostomia Inventory; Diagnostic Test: Sialometry

Interventions

Summated Xerostomia Inventory DIAGNOSTIC_TEST

structured interview by a dedicated researcher to obtain a score of the summated xerostomia inventory (SXI)

Control; Interventional

Sialometry DIAGNOSTIC_TEST

unstimulated whole saliva (UWS) flow measurement

Control; Interventional

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (2)

• Gravenmade 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 BACKGROUND

• Marimuthu 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 DERIVED

MeSH Terms

Conditions

Xerostomia; Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Mawaddah Azman, MS

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessor blinded to allocation of treatment, which was only revealed after completion of data collection
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: June 5, 2018
• Primary Completion: January 5, 2020
• Study Completion: March 5, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)