Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation
2 other identifiers
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2007
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedResults Posted
Study results publicly available
April 11, 2014
CompletedApril 11, 2014
February 1, 2013
1 year
September 20, 2011
March 7, 2014
March 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.
7 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPatients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Low Level Laser Therapy
EXPERIMENTALThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients using medication for treatment and or prevention of mucositis
- Patients incapable of treatment compliance or of performing the protocol of oral hygiene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil
Related Publications (1)
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.
PMID: 26559740DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Heliton Spindola Antunes
- Organization
- Instituto Nacional de Cancer
Study Officials
- PRINCIPAL INVESTIGATOR
Heliton S Antunes, DDS, PhD
Instituto Nacional de Cancer, Brazil
- STUDY DIRECTOR
Carlos G Ferreira, MD, PhD
Instituto Nacional de Cancer, Brazil
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 23, 2011
Study Start
June 1, 2007
Primary Completion
June 1, 2008
Study Completion
December 1, 2010
Last Updated
April 11, 2014
Results First Posted
April 11, 2014
Record last verified: 2013-02