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
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Condition or disease | Intervention/treatment | Phase |
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Oral Mucositis | Device: Low intensity laser for oral mucositis Device: Low intensity laser for oral mucositis switch off | Phase 4 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Low energy laser
Administration of a low energy laser for oral mucositis.
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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 |
- 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 ]
- 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 ]
- 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 ]
- Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment. [ Time Frame: 24 months ]
- Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment. [ Time Frame: 24 months ]
- Assess the intervention tolerance and side effects of it. [ Time Frame: 24 months ]

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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 |
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.

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
Contact: Daniel Torres Lagares | danieltl@us.es | ||
Contact: María del Mar Benjumea Vargas | 955 04 04 50 | gestionensayosclinicos.fps@juntadeandalucia.es |
Spain | |
Hospital Universitario Virgen del Rocío | Recruiting |
Sevilla, Spain, 41013 | |
Contact: Daniel Torres Lagares danieltl@us.es | |
Principal Investigator: Daniel Torres Lagares |
Principal Investigator: | Daniel Torres Lagares | Hospitales Universitarios Virgen del Rocío |
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 |
Mucositis Stomatitis Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Mouth Diseases Stomatognathic Diseases |