Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Location status: Recruiting
Location contact
Basma Morsy, MSc
PRINCIPAL_INVESTIGATOR
Fatma Amin, professor
CONTACT
NCT Number: NCT07476209
Radiation induced xerostomia (RIX) represents a common debilitating side effect for (RT), adversely affecting oral health and hindering head and neck cancer (HNC) patients' quality of life (QOL). To date, managing (RIX) is mainly symptomatic, while the only FDA-approved preventive therapeutic agent is Amifostine, with associated systemic toxicities. Sialendoscopic management is a minimally invasive technique that can help in restoring ductal patency, decreasing inflammation and improving salivary flow. Laser Photobiomodulation (PBM) is a noninvasive approach that enhances salivary gland function by stimulating cellular activity, increasing blood flow and attenuating oxidative stress.
Aim: The present study aims to evaluate and compare the efficacy of sialendoscopic management and photobiomodulation in managing (RIX) in (HNC) patients.
Materials and Methods: A randomized clinical trial will be carried out on 42 (HNC) patients. Directly prior to the first (RT) session, Group I (n= 14 patients) will receive sialendoscopic management. Group II (n=14 patients) will receive (PBM) sessions. Group III (n= 14 patients) will receive basic oral care (BOC). Xerostomia will be evaluated at baseline, at 3 weeks and after 8 weeks from the end of (RT), clinically using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and objectively using unstimulated salivary flow. Quality of life will be assessed using Multidisciplinary Salivary Gland Society (MSGS) questionnaire. Salivary amylase will be assessed at baseline and after 8 weeks from the end of (RT).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Alexandria, Egypt
Location status: Recruiting
Basma Morsy, MSc
PRINCIPAL_INVESTIGATOR
Fatma Amin, professor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive sialendoscopic management using an all-in-one 1.3-mm Marchal sialendoscope. The Endoscope will be introduced in the duct lumen after dilation of papilla under microscopic magnification, using salivary dilators and a conical probe. The ductal system will be irrigated with a steroid (Triamcinolone acetonide-40mg/ml) diluted in 9mL of sterile saline solution41. The procedure will be done for all patients, directly before their 1st radiotherapy session
Patients will receive laser photobiomodulation sessions (twice/week) for 6 weeks (total of 12 sessions), directly before their 1st (RT) session, using (980nm) diode laser.
Time frame: from baseline to two months following the end of radiation
Xerostomia grade will be assessed based on clinical implications and activity impact from Common Terminology Criteria for Adverse Events (CTCAE) v5.0. at baseline, 3 weeks (during RT) and 8 weeks (after the end of RT).
Xerostomia is graded from 1 to 3 based on symptom severity and dietary impact.
Time frame: From baseline to two months after the end of Radiation
Using Multidisciplinary Salivary Gland Society (MSGS) questionnaire It includes 20 questions with scores from 0 to 10. where 0 indicates normal condition and 10 indicates maximum severity.
Contact information is provided by the study sponsor or research team.
Alexandria University
Other
Sialendoscopic Management Versus Photobiomodulation in Prevention of Radiation-induced Xerostomia in Head and Neck Cancer Patients (Randomized Clinical Trial)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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