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

Instituto Nacional de Cancer, Brazil

Status and phase: Completed; Phase 3

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01439724

Protocol 17/2007 (Registry Identifier)

INCABrazil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

Treatment:

Device: Placebo (DMC, São Paulo, Brazil)

Low Level Laser Therapy

Experimental group

Description:

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.

Treatment:

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