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

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ClinicalTrials.gov Identifier: NCT01439724
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : April 11, 2014
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Cancer, Brazil

Study Description
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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.

Condition or disease Intervention/treatment 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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Low Level Laser Therapy, diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439724


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT01439724    
Other Study ID Numbers: INCABrazil
Protocol 17/2007 ( Registry Identifier: Protocol 17/2007 )
First Posted: September 23, 2011    Key Record Dates
Results First Posted: April 11, 2014
Last Update Posted: April 11, 2014
Last Verified: February 2013
Keywords provided by Instituto Nacional de Cancer, Brazil:
Oral mucositis
Low Level Laser Therapy
Head and neck cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Carcinoma
Mucositis
Stomatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases