Squamous Cell Carcinoma of Oropharynx Clinical Trial
Official title:
Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation
Verified date | February 2013 |
Source | Instituto Nacional de Cancer, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ministry of Health |
Study type | Interventional |
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 as a promising, preventive therapy of chemoradiation-induced OM. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.
Status | Completed |
Enrollment | 94 |
Est. completion date | December 2010 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - Patients using medication for treatment and or prevention of mucositis - Patients incapable of treatment compliance or of performing the protocol of oral hygiene |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Nacional de Cancer | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cancer, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and / or Severity of Oral Mucositis | The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment. | 7 weeks | No |
Secondary | Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy. | Oral mucositis survival free, pain, opioid treatment, hospitalization, treatment interruption, treatment delay, patient weight loss, nasogastric tube or of a gastrostomy.The oral cavities of all patients were evaluated, from the first day to the last day of treatment. | 7 weeks | No |
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