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Phase 4
18 Years
80 Years
Open (Enrolling)
Oral Mucositis

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Trial Information

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Daniel Torres Lagares

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario Virgen del Rocío


Spain: Ethics Committee

Study ID:




Start Date:

January 2013

Completion Date:

Related Keywords:

  • Oral Mucositis
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis