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
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Condition or disease | Intervention/treatment | Phase |
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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 (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 |

Arm | Intervention/treatment |
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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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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:
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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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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:
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- 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.
- 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.

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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 |
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

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
Brazil | |
Instituto Nacional de Cancer | |
Rio de Janeiro, Brazil, 20231-050 |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Oral mucositis Low Level Laser Therapy Head and neck cancer |
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 |