CompletedNot Applicable

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

Malaysia94 participantsStarted 2018-06-05

Plain-language 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.

Who can participate

Age range

20 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

summated xerostomia inventory (SXI) score

Timeframe: 4 weeks

Trial details

NCT IDNCT04491435

SponsorUniversiti Kebangsaan Malaysia Medical Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-05

View on ClinicalTrials.gov More Xerostomia, Hyposalivation, Saliva Substitute, Radiation-induced Toxicity, Nasopharyngeal Cancer trials