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Completed

NCT Number: NCT01439724

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

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.

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Key information

Conditions

Squamous Cell Carcinoma of Nasopharynx Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of Hypopharynx Squamous Cell Carcinoma of Oropharynx Stomatitis Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Nacional de Cancer

Rio de Janeiro, 20231-050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 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.

Other names: Low Power Laser Therapy, Low Energy Laser Therapy

Placebo (DMC, São Paulo, Brazil)

Device

The placebo (DMC, São Paulo, Brazil) 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.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

Other names: Low power laser therapy, Low energy laser therapy

Primary outcomes

  1. Incidence and / or Severity of Oral Mucositis

    Time frame: 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 outcomes

  1. Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancer, Brazil

Other Gov

Registry information

Official study title

Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Sep 23, 2011
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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