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

Study Overview
=================
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.

Conditions
-----------------
Oral Mucositis

Intervention / Treatment
-----------------
* Device: Low intensity laser for oral mucositis
* Device: Low intensity laser for oral mucositis switch off


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low energy laser<br>Administration of a low energy laser for oral mucositis. | Device: Low intensity laser for oral mucositis<br> <br> |
| Placebo Comparator: Placebo<br> | Device: Low intensity laser for oral mucositis switch off<br>* Low intensity laser for oral mucositis switch off<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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. |  | 24 months | 
| Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment. |  | 24 months | 
| Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment. |  | 24 months | 
| Assess the intervention tolerance and side effects of it. |  | 24 months |