Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia

Condition(s) studied

Investigational drug(s) / intervention(s)

Sialendoscopy: 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

Photobiomodulation: 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.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Xerostomia grade — 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.

Trial sites (1)

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