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

Oral Mucositis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01876407
• Other study ID #: FPS-LAS-2012-04
• Secondary ID: 001001006001
• Status: Recruiting
• Phase: Phase 4
• First received: June 10, 2013
• Last updated: February 4, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: Daniel Torres Lagares
• Email: danieltl[@]us.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• Low intensity laser for oral mucositis

• Low intensity laser for oral mucositis switch off
Low intensity laser for oral mucositis switch off

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.		24 months	Yes
Secondary	Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.		24 months	Yes
Secondary	Assess the intervention tolerance and side effects of it.		24 months	Yes