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

Fundación Pública Andaluza Progreso y Salud

Status and phase

Unknown

Phase 4

Conditions

Oral Mucositis

Treatments

Device: Low intensity laser for oral mucositis

Device: Low intensity laser for oral mucositis switch off

Study type

Interventional

Funder types

Other

Identifiers

NCT01876407

001001006001 (Other Grant/Funding Number)

FPS-LAS-2012-04

Details and patient eligibility

About

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.

Enrollment

126 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.