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

Squamous Cell Carcinoma of Oropharynx Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439724
• Other study ID #: INCABrazil
• Secondary ID: Protocol 17/2007
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2011
• Last updated: March 7, 2014
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: Instituto Nacional de Cancer, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2010
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Mucositis
• Nasopharyngeal Neoplasms
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of Hypopharynx
• Squamous Cell Carcinoma of Nasopharynx
• Squamous Cell Carcinoma of Oropharynx
• Stomatitis

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Cancer	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and / or Severity of Oral Mucositis	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.	7 weeks	No
Secondary	Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.	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.	7 weeks	No

External Links

•   Click here for more information about Instituto Nacional de Cancer- Brazil