Status:
UNKNOWN
Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
Lead Sponsor:
Fundación Pública Andaluza Progreso y Salud
Conditions:
Oral Mucositis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01876407
Start Date
January 1 2013
End Date
July 1 2016
Last Update
February 5 2016
Active Locations (1)
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1
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013