Efficacy of photobiomodulation (Low-Level Laser Therapy) for management of radiation induced mucositis in carcinoma oral cavity patients: An open label prospective randomized controlled trial

Oral mucositis is the most debilitating complication in the treatment of oral cavity cancer patients undergoing radiotherapy. Severe mucositis can result in treatment interruptions and unsatisfactory results of treatment. While mucositis is observed in almost all patients undergoing radiotherapy alone or with concurrent chemotherapy, the current practice of prescribing only supportive measures has not been very effective in the treatment and prevention of mucositis. Low-level laser therapy (LLLT) has proven to effectively reduce the incidence and progression of mucositis in patients undergoing radiotherapy with concurrent chemotherapy over the years. The aim of this prospective randomized controlled trial (RCT) is to evaluate the effectiveness of LLLT treatment for Radiation induced oral mucositis, in oral cavity cancer patients.

In 2014, the Multinational Association for Supportive Care in Cancer (MASCC), included laser therapy as a “suggested†treatment of oral mucositis in patients receiving head and neck radiotherapy without chemotherapy and changed it to a “recommendation†in the 2020 update. Another guideline for the use of photobiomodulation in patients receiving concurrent chemotherapy has also been added in the 2020 update. The guideline recommends the use of 632.8nm wavelength in patients receiving only RT and 600nm in concurrent chemotherapy.

The study will be conducted on 80 patients who are undergoing radiotherapy with concurrent chemotherapy in radical or adjuvant setting. Radiotherapy dose will be from 60 - 70Gy (2Gy/ fraction) as per the disease with 5 fractions per week. Concurrent chemotherapy will be Cisplatin 40 mg/m2 weekly and will be given wherever clinically indicated. Patients will be divided into study and control groups (40 patients in each group) and both groups being prescribed the standard supportive medications for mucositis i.e.benzydamine mouth wash, povidone-iodine, and soda bicarbonate gargles, analgesics, and educated regarding good oral hygiene practices. All patients will be monitored once a week starting from the first week of treatment and the mucositis will be graded based on the RTOG grading system. Low level laser will be applied to patients who develop grade II mucositis, in a scanning motion, 5 times a week, using a handheld diode laser ( NLase by IndiLase, Medsol) of 660-nm (visible red) wavelength and output power of 100mW. The exposure time on each point of the ulcer will be 10s; hence the total energy delivered per point will be 1J. The changes in the grade of mucositis will be noted during the weekly clinical assessment. The patients will be followed up weekly during the treatment and monthly after completion of treatment upto 3 months