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

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ClinicalTrials.gov Identifier: NCT04491435
Recruitment Status : Completed
First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

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.

Condition or disease Intervention/treatment Phase
Xerostomia, Hyposalivation, Saliva Substitute, Radiation-induced Toxicity, Nasopharyngeal Cancer Diagnostic Test: Summated Xerostomia Inventory Diagnostic Test: Sialometry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and outcome assessor blinded to allocation of treatment, which was only revealed after completion of data collection
Primary Purpose: Supportive Care
Official Title: Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : January 5, 2020
Actual Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: Interventional
4 weeks use of mucin-based saliva substitute
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

Placebo Comparator: Control
4 weeks use of xylitol-based mouthwash
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




Primary Outcome Measures :
  1. summated xerostomia inventory (SXI) score [ Time Frame: 4 weeks ]
    summated xerostomia inventory (SXI) score at baseline-summated xerostomia inventory (SXI) score at 4 weeks post intervention


Secondary Outcome Measures :
  1. unstimulated whole saliva (UWS) flow [ Time Frame: 4 weeks ]
    unstimulated whole saliva (UWS) flow at 4 weeks post intervention -unstimulated whole saliva (UWS) flow at baseline



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Sjớgren syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491435


Locations
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Malaysia
Universiti Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
Investigators
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Principal Investigator: Mawaddah Azman, MS National University of Malaysia
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT04491435    
Other Study ID Numbers: FF2018-133
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be shared upon publication of the research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Xerostomia
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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type