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

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ClinicalTrials.gov Identifier: NCT01439724
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : April 11, 2014
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Cancer, Brazil

Tracking Information
First Submitted Date  ICMJE September 20, 2011
First Posted Date  ICMJE September 23, 2011
Results First Submitted Date  ICMJE March 7, 2014
Results First Posted Date  ICMJE April 11, 2014
Last Update Posted Date April 11, 2014
Study Start Date  ICMJE June 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2011)
Incidence and / or Severity of Oral Mucositis [ Time Frame: 7 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2011)
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 ]
The oral cavities of all patients were evaluated daily, from the first day to the last day of treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Official Title  ICMJE Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Squamous Cell Carcinoma of Nasopharynx
  • Squamous Cell Carcinoma of Oropharynx
  • Squamous Cell Carcinoma of Hypopharynx
Intervention  ICMJE
  • Device: Low Level Laser Therapy- (DMC, São Paulo, Brazil)
    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.
    Other Names:
    • Low Power Laser Therapy
    • Low Energy Laser Therapy
  • Device: Placebo (DMC, São Paulo, Brazil)
    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.
    Other Names:
    • Low power laser therapy
    • Low energy laser therapy
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
    Intervention: Device: Placebo (DMC, São Paulo, Brazil)
  • Experimental: Low Level Laser Therapy
    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: Device: Low Level Laser Therapy- (DMC, São Paulo, Brazil)
Publications * Antunes HS, Schluckebier LF, Herchenhorn D, Small IA, Araújo CM, Viégas 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2011)
94
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01439724
Other Study ID Numbers  ICMJE INCABrazil
Protocol 17/2007 ( Registry Identifier: Protocol 17/2007 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto Nacional de Cancer, Brazil
Study Sponsor  ICMJE Instituto Nacional de Cancer, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heliton S Antunes, DDS, PhD Instituto Nacional de Cancer, Brazil
Study Director: Carlos G Ferreira, MD, PhD Instituto Nacional de Cancer, Brazil
PRS Account Instituto Nacional de Cancer, Brazil
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP