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Trial record 1 of 2 for:    Low Energy Laser Treatment in Oral Mucositis
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Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01876407
Recruitment Status : Unknown
Verified February 2016 by Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud ).
Recruitment status was:  Recruiting
First Posted : June 12, 2013
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oral Mucositis Device: Low intensity laser for oral mucositis Device: Low intensity laser for oral mucositis switch off Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low energy laser
Administration of a low energy laser for oral mucositis.
 Device: Low intensity laser for oral mucositis
Placebo Comparator: Placebo Device: Low intensity laser for oral mucositis switch off
Low intensity laser for oral mucositis switch off


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment. [ Time Frame: 24 months ]
  4. Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment. [ Time Frame: 24 months ]
  5. Assess the intervention tolerance and side effects of it. [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876407


Contacts
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Contact: Daniel Torres Lagares danieltl@us.es
Contact: María del Mar Benjumea Vargas 955 04 04 50 gestionensayosclinicos.fps@juntadeandalucia.es

Locations
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Spain
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Contact: Daniel Torres Lagares       danieltl@us.es   
Principal Investigator: Daniel Torres Lagares         
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
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Principal Investigator: Daniel Torres Lagares Hospitales Universitarios Virgen del Rocío
More Information
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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01876407    
Other Study ID Numbers: FPS-LAS-2012-04
001001006001 ( Other Grant/Funding Number: AETSA )
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases