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Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer

NCT01772706 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2019-01-07

No results posted yet for this study

Summary

The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.

Conditions

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Oropharynx
  • Squamous Cell Carcinoma of Hypopharynx
  • Oral Mucositis

Interventions

PROCEDURE

low level laser therapy

PROCEDURE

placebo (laser low level energy nonfunctional)

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Eric JADAUD, MD · Institut de Cancerologie de l'Ouest - Paul Papin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-30
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772706 on ClinicalTrials.gov