Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients

Phase 3

Completed

Conditions: Squamous Cell Carcinoma of Hypopharynx
Squamous Cell Carcinoma of Oropharynx
Squamous Cell Carcinoma of Nasopharynx

Interventions: Device: Placebo (DMC, São Paulo, Brazil)
Device: Low Level Laser Therapy- (DMC, São Paulo, Brazil)

Brief Summary: Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.

Detailed Description: Assuming oral mucositis grade 3 for placebo 0.4 (P0); laser group 0.15 (P1) ; β=0.2; α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 laser group and 47 placebo patients bearer of head and neck squamous cell carcinomas of nasopharynx, oropharynx and hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. chemoradiotherapy consisted of conventional radiotherapy 70.2 Gray (Gy) (1.8Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 weeks. The primary end point was the incidence of grade 3-4 oral mucositis. The Low-level laser therapy used daily, was a diode indium phosphide, gallium and aluminum (InGaAlP), 660nm-100 milliwatts (mW)-4 Joules (J)/cm²(DMC, São Carlos, São Paulo, Brazil). Oral mucositis evaluation was done by WHO and Oral Mucositis Assessment Scale (OMAS) scale.

Recruitment & Eligibility

Inclusion Criteria

Age ≥ 18 years
Histological diagnosis of squamous cell carcinoma (nasopharynx, oropharynx and hypopharynx)
Candidates for surgery or treatment for organ preservation
Performance status (PS) of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG)
Indication for radiotherapy and concurrent platinum-based chemotherapy
Oral mucosa intact
Agree to follow the protocol of oral hygiene
Informed consent.

Exclusion Criteria

Patients using medication for treatment and or prevention of mucositis
Patients incapable of treatment compliance or of performing the protocol of oral hygiene

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (DMC, São Paulo, Brazil)	Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Low Level Laser Therapy	Low Level Laser Therapy- (DMC, São Paulo, Brazil)	The investigators used a Low Level Laser Therapy, diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.

Primary Outcome Measures

Name	Time	Method
Incidence and / or Severity of Oral Mucositis	7 weeks	The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.

Secondary Outcome Measures

Name	Time	Method
Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.	7 weeks	Oral mucositis survival free, pain, opioid treatment, hospitalization, treatment interruption, treatment delay, patient weight loss, nasogastric tube or of a gastrostomy.The oral cavities of all patients were evaluated, from the first day to the last day of treatment.