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NCT01439724 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2014-04-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Incidence and / or Severity of Oral Mucositis

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outcome · NOT POSTED

Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
    intervention Names
    1. Device: Placebo (DMC, São Paulo, Brazil)
    label
    Placebo
    type
    PLACEBO_COMPARATOR
  2. description
    The investigators used a Low Level Laser Therapy, diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
    intervention Names
    1. Device: Low Level Laser Therapy- (DMC, São Paulo, Brazil)
    label
    Low Level Laser Therapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Low Level Laser Therapy
    description
    Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
    name
    Low Level Laser Therapy- (DMC, São Paulo, Brazil)
    other Names
    1. Low Power Laser Therapy
    2. Low Energy Laser Therapy
    type
    DEVICE
  2. arm Group Labels
    1. Placebo
    description
    The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
    name
    Placebo (DMC, São Paulo, Brazil)
    other Names
    1. Low power laser therapy
    2. Low energy laser therapy
    type
    DEVICE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
PREVENTION
Enrollment
count
94
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Incidence and / or Severity of Oral Mucositis
    time Frame
    7 weeks
secondary Outcomes
  1. description
    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.
    measure
    Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.
    time Frame
    7 weeks
Full study description
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 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.
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 and neck squamous cell carcinomas of nasopharynx, oropharynx and hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. chemoradiotherapy consisted of conventional radiotherapy 70.2 Gray (Gy) (1.8Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 weeks. The primary end point was the incidence of grade 3-4 oral mucositis. The Low-level laser therapy used daily, was a diode indium phosphide, gallium and aluminum (InGaAlP), 660nm-100 milliwatts (mW)-4 Joules (J)/cm²(DMC, São Carlos, São Paulo, Brazil). Oral mucositis evaluation was done by WHO and Oral Mucositis Assessment Scale (OMAS) scale.
Source references
references
  1. citation
    Antunes HS, Schluckebier LF, Herchenhorn D, Small IA, Araujo CM, Viegas CM, Rampini MP, Ferreira EM, Dias FL, Teich V, Teich N, Ferreira CG. Cost-effectiveness of low-level laser therapy (LLLT) in head and neck cancer patients receiving concurrent chemoradiation. Oral Oncol. 2016 Jan;52:85-90. doi: 10.1016/j.oraloncology.2015.10.022. Epub 2015 Nov 11.
    pmid
    26559740
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
      ds-hypopharyngeal-cancer
      source file
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      source string sha256
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    Preserved source evidence · Not medical advice