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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier:
NCT01439724
First received: September 20, 2011
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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 LLLT in reducing the incidence and/or severity of oral mucositis.


Condition Intervention Phase
Squamous Cell Carcinoma of Nasopharynx
Squamous Cell Carcinoma of Oropharynx
Squamous Cell Carcinoma of Hypopharynx
 Device: Low Level Laser Therapy- (DMC, São Paulo, Brazil)
Device: Placebo (DMC, São Paulo, Brazil)
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Cancer, Brazil:

Primary Outcome Measures:
  • Incidence and / or severity of oral mucositis [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The oral cavities of all patients were evaluated daily, from the first day to the last day of treatment.


Enrollment: 94
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
 Device: 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.
Other Names:
  • Low power laser therapy
  • Low energy laser therapy
Experimental: Low Level Laser Therapy
The investigators used a 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.
 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.
Other Names:
  • Low Power Laser Therapy
  • Low Energy Laser Therapy

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439724

Locations
Brazil
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20231-050
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Investigators
Principal Investigator: Heliton S Antunes, DDS, MSc, PhD Instituto Nacional de Cancer, Brazil
Study Director: Carlos G Ferreira, MD, PhD Instituto Nacional de Cancer, Brazil
  More Information

Additional Information:
Click here for more information about Instituto Nacional de Cancer- Brazil  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT01439724     History of Changes
Other Study ID Numbers: INCABrazil, Protocol 17/2007
Study First Received: September 20, 2011
Last Updated: February 6, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Instituto Nacional de Cancer, Brazil:
Oral mucositis
Low Level Laser Therapy
Head and neck cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Stomatitis
Hypopharyngeal Neoplasms
Mucositis
Oropharyngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Nasopharyngeal Diseases

ClinicalTrials.gov processed this record on May 22, 2013