Clinical trial NCT01439724: Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Official title: Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of Nasopharynx
Squamous Cell Carcinoma of Oropharynx
Squamous Cell Carcinoma of Hypopharynx
Keywords: Oral mucositis
Low Level Laser Therapy
Head and neck cancer
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2011-09-23
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence and / or Severity of Oral Mucositis
timeFrame: 7 weeks
Secondary outcomes:
measure: Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
Study officials:
affiliation: Instituto Nacional de Cancer, Brazil
name: Heliton S Antunes, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cancer, Brazil
name: Carlos G Ferreira, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Antunes HS, Schluckebier LF, Herchenhorn D, Small IA, Araujo CM, Viegas CM, Rampini MP, Ferreira EM, Dias FL, Teich V, Teich N, Ferreira CG. Cost-effectiveness of low-level laser therapy (LLLT) in head and neck cancer patients receiving concurrent chemoradiation. Oral Oncol. 2016 Jan;52:85-90. doi: 10.1016/j.oraloncology.2015.10.022. Epub 2015 Nov 11.