Oral Mucositis
Conditions
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.
Interventions
DEVICELow intensity laser for oral mucositis
DEVICELow intensity laser for oral mucositis switch off
Low intensity laser for oral mucositis switch off
Sponsors
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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. | 24 months |
Secondary
| 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. | 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 |
Countries
Spain
Contacts
Primary ContactDaniel Torres Lagares
Backup ContactMaría del Mar Benjumea Vargas
Outcome results
None listed