Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer

February 4, 2016 updated by: Fundación Pública Andaluza Progreso y Salud
The purpose of this study is to evaluate the effectiveness of using to low intensity laser as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and chemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 4

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

  • Spain
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Daniel Torres Lagares

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with squamous cell carcinoma of the oral cavity.
  • Patients aged between 18 and 80 years.
  • Patients who are to receive one of the following treatment
  • Combined radiotherapy (conventional fractionation 70 Gy reaching the tumor and affected lymph nodes, and 50 Gy in the areas ganglion drainage) and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22 and 43 irradiation or cetuximab 400mg/m2 as a single dose pre-load radiotherapy and 250mg/m2 weekly for the same. Regardless of whether they have received previous surgical treatment.
  • Treatment with radiotherapy of 70 Gy in 35 daily sessions 2Gy/día consecutive.
  • Patients who voluntarily express their intention to participate by informed consent.

Exclusion Criteria:

  • Patients who denied informed consent.
  • Patients who have hypersensitivity or allergy to any of the components included in the study.
  • Patients diagnosed with HIV, and autoimmune diseases.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Device: Low intensity laser for oral mucositis switch off
Low intensity laser for oral mucositis switch off
EXPERIMENTAL: Low energy laser
Administration of a low energy laser for oral mucositis.
Device: Low intensity laser for oral mucositis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the effectiveness of using low-intensity laser compared with placebo as preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the effectiveness of using low level laser compared with placebo in the prevention of onset of oral mucositis induced by treatment of head and neck QRT.
Time Frame: 24 months
24 months
Evaluate the effectiveness of the use of low laser intensity versus placebo in improving the healing of oral mucositis induced by treatment of head and neck QRT.
Time Frame: 24 months
24 months
Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.
Time Frame: 24 months
24 months
Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.
Time Frame: 24 months
24 months
Assess the intervention tolerance and side effects of it.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Investigators

  • Principal Investigator: Daniel Torres Lagares, Hospitales Universitarios Virgen del Rocío

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

January 1, 2013

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (ESTIMATE)

June 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPS-LAS-2012-04
  • 001001006001 (OTHER_GRANT: AETSA)

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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