CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 94 enrolled
Drug / intervention
Low Level Laser Therapy- (DMC, São Paulo, Brazil) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01439724
NCT01439724Phase 3Completed
CompareCT.gov

Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation

Instituto Nacional de Cancer, Brazil·interventional·Posted Sep 23, 2011·Updated Apr 11, 2014

In Brief

A Phase 3 clinical trial evaluating Low Level Laser Therapy- (DMC, São Paulo, Brazil) and Placebo (DMC, São Paulo, Brazil) for Squamous Cell Carcinoma of Nasopharynx and 2 related conditions. Completed, enrolled 94 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of Nasopharynx, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 23, 2011
Enrollment StartJun 1, 2007
Primary CompletionJun 1, 2008
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.8 years ago

Interventions

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

Placebo (DMC, São Paulo, Brazil)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.