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

Phase 3
18 Years
75 Years
Not Enrolling
Squamous Cell Carcinoma of Nasopharynx, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx

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Trial Information

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

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 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
InGaAlP, 660nm-100mW-4J/cm²(DMC, São Carlos, São Paulo, Brazil). Oral mucositis evaluation
was done by WHO and Oral Mucositis Assessment Scale (OMAS) scale.

Inclusion Criteria:

- Age ≥ 18 years

- Histological diagnosis of squamous cell carcinoma (nasopharynx, oropharynx and

- Candidates for surgery or treatment for organ preservation

- Performance status (PS) of 0 or 1 according to the Eastern Cooperative Oncology Group

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Incidence and / or severity of oral mucositis

Outcome Description:

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.

Outcome Time Frame:

7 weeks

Safety Issue:


Principal Investigator

Heliton S Antunes, DDS, MSc, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Nacional de Cancer, Brazil


Brazil: Ministry of Health

Study ID:




Start Date:

June 2007

Completion Date:

December 2010

Related Keywords:

  • Squamous Cell Carcinoma of Nasopharynx
  • Squamous Cell Carcinoma of Oropharynx
  • Squamous Cell Carcinoma of Hypopharynx
  • Oral mucositis
  • Low Level Laser Therapy
  • Head and neck cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Stomatitis
  • Hypopharyngeal Neoplasms
  • Mucositis
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms