Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
NCT ID: NCT01876407
Last Updated: 2016-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
126 participants
INTERVENTIONAL
2013-01-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low-Level Laser Therapy for Prevention of Oral Mucositis
NCT02723604
Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention
NCT04717765
Low-energy Laser Therapy for Prevention of Oral Mucositis in Children
NCT01007617
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer
NCT01772706
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
NCT01439724
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low energy laser
Administration of a low energy laser for oral mucositis.
Low intensity laser for oral mucositis
Placebo
Low intensity laser for oral mucositis switch off
Low intensity laser for oral mucositis switch off
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low intensity laser for oral mucositis
Low intensity laser for oral mucositis switch off
Low intensity laser for oral mucositis switch off
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 have hypersensitivity or allergy to any of the components included in the study.
* Patients diagnosed with HIV, and autoimmune diseases.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Torres Lagares
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
001001006001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FPS-LAS-2012-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.