Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
Primary Purpose
Oral Mucositis
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Low intensity laser for oral mucositis
Low intensity laser for oral mucositis switch off
Sponsored by
About this trial
This is an interventional treatment trial for Oral Mucositis
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.
Sites / Locations
- Hospital Universitario Virgen del RocíoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Low energy laser
Placebo
Arm Description
Administration of a low energy laser for oral mucositis.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.
Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.
Assess the intervention tolerance and side effects of it.
Full Information
NCT ID
NCT01876407
First Posted
June 10, 2013
Last Updated
February 4, 2016
Sponsor
Fundación Pública Andaluza Progreso y Salud
1. Study Identification
Unique Protocol Identification Number
NCT01876407
Brief Title
Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza Progreso y Salud
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low energy laser
Arm Type
Experimental
Arm Description
Administration of a low energy laser for oral mucositis.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Low intensity laser for oral mucositis
Intervention Type
Device
Intervention Name(s)
Low intensity laser for oral mucositis switch off
Intervention Description
Low intensity laser for oral mucositis switch off
Primary Outcome Measure Information:
Title
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 months
Title
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.
Time Frame
24 months
Title
Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.
Time Frame
24 months
Title
Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.
Time Frame
24 months
Title
Assess the intervention tolerance and side effects of it.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Torres Lagares
Email
danieltl@us.es
First Name & Middle Initial & Last Name or Official Title & Degree
María del Mar Benjumea Vargas
Phone
955 04 04 50
Email
gestionensayosclinicos.fps@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Torres Lagares
Organizational Affiliation
Hospitales Universitarios Virgen del Rocío
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Torres Lagares
Email
danieltl@us.es
First Name & Middle Initial & Last Name & Degree
Daniel Torres Lagares
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
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