Phase 3
N=94
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Squamous Cell Carcinoma of Nasopharynx · Squamous Cell Carcinoma of Oropharynx · Squamous Cell Carcinoma of Hypopharynx
Bottom Line
View on ClinicalTrials.gov: NCT01439724 ↗Enrolled (actual)
94
Serious AEs
34.0%
Results posted
Apr 2014
Primary outcome: Primary: Incidence and / or Severity of Oral Mucositis — 19; 3 Grade 3-4 oral mucositis — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Low Level Laser Therapy- (DMC, São Paulo, Brazil) (Device); Placebo (DMC, São Paulo, Brazil) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Instituto Nacional de Cancer, Brazil
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and / or Severity of Oral Mucositis |
19; 3 | 0.05 |
| SECONDARY Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy. |
— | — |
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 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01439724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.