MedTrace Logo

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

NCT04491435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2020-07-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

    lead OTHER

Principal Investigators

  • Mawaddah Azman, MS · National University of Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2020-01-05
Completion
2020-03-05

Countries

  • Malaysia

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491435 on ClinicalTrials.gov