Phase 3 Completed N=94 Randomized Triple-blind Prevention

Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients

Head and Neck Cancer · Squamous Cell Carcinoma of Oropharynx · Squamous Cell Carcinoma of Hypopharynx

Source: ClinicalTrials.gov NCT01439724 ↗

Enrolled (actual)

Serious AEs

34.0%

Results posted

Apr 2014

Primary outcomePrimary: Incidence and / or Severity of Oral Mucositis — 19; 3 Grade 3-4 oral mucositis — p=0.05

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.

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.	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.