- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01439724
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
March 7, 2014 updated by: Instituto Nacional de Cancer, Brazil
Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
94
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio de Janeiro, Brazil, 20231-050
- Instituto Nacional de Cancer
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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.
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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:
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and / or Severity of Oral Mucositis
Time Frame: 7 weeks
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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.
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7 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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7 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Heliton S Antunes, DDS, PhD, Instituto Nacional de Cancer, Brazil
- Study Director: Carlos G Ferreira, MD, PhD, Instituto Nacional de Cancer, Brazil
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ACTUAL)
June 1, 2008
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
September 20, 2011
First Submitted That Met QC Criteria
September 22, 2011
First Posted (ESTIMATE)
September 23, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
April 11, 2014
Last Update Submitted That Met QC Criteria
March 7, 2014
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Diseases
- Gastroenteritis
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Neoplasms, Squamous Cell
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Carcinoma, Squamous Cell
- Mucositis
- Stomatitis
Other Study ID Numbers
- INCABrazil (Instituto Nacional de Câncer)
- Protocol 17/2007 (REGISTRY: Protocol 17/2007)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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