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

NCT ID: NCT01439724

Last Updated: 2014-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-12-31

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.

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.

Conditions

Squamous Cell Carcinoma of Nasopharynx; Squamous Cell Carcinoma of Oropharynx; Squamous Cell Carcinoma of Hypopharynx

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

Group Type: PLACEBO_COMPARATOR

Placebo (DMC, São Paulo, Brazil)

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Low Level Laser Therapy- (DMC, São Paulo, Brazil)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Low Power Laser Therapy; Low Energy Laser Therapy; Low power laser therapy; Low energy laser therapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heliton S Antunes, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancer, Brazil

Carlos G Ferreira, MD, PhD

Role: STUDY_DIRECTOR

Instituto Nacional de Cancer, Brazil

Locations

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 26559740 (View on PubMed)

Related Links

http://www.inca.gov.br

Click here for more information about Instituto Nacional de Cancer- Brazil

Other Identifiers

Protocol 17/2007

Identifier Type: REGISTRY

Identifier Source: secondary_id

INCABrazil

Identifier Type: -

Identifier Source: org_study_id