Status:
COMPLETED
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Squamous Cell Carcinoma of Nasopharynx
Squamous Cell Carcinoma of Oropharynx
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges ...
Detailed Description
Assuming oral mucositis grade 3 for placebo 0.4 (P0); laser group 0.15 (P1) ; β=0.2; α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 laser group and 47 placebo patients bearer of head an...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histological diagnosis of squamous cell carcinoma (nasopharynx, oropharynx and hypopharynx)
- Candidates for surgery or treatment for organ preservation
- Performance status (PS) of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG)
- Indication for radiotherapy and concurrent platinum-based chemotherapy
- Oral mucosa intact
- Agree to follow the protocol of oral hygiene
- Informed consent.
Exclusion
- Patients using medication for treatment and or prevention of mucositis
- Patients incapable of treatment compliance or of performing the protocol of oral hygiene
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01439724
Start Date
June 1 2007
End Date
December 1 2010
Last Update
April 11 2014
Active Locations (1)
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1
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil, 20231-050