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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Squamous Cell Carcinoma of Nasopharynx
Squamous Cell Carcinoma of Oropharynx
Squamous Cell Carcinoma of Hypopharynx
Interventions Device: Low Level Laser Therapy- (DMC, São Paulo, Brazil)
Device: Placebo (DMC, São Paulo, Brazil)
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Low Level Laser Therapy
Hide Arm/Group Description

Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

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.

The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4 Joules(J)/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.

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.

Period Title: Overall Study
Started 47 47
Completed 38 39
Not Completed 9 8
Reason Not Completed
missing consultation             9             8
Arm/Group Title Placebo Low Level Laser Therapy Total
Hide Arm/Group Description

Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

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.

The investigators used a 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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 47 47 94
Hide Baseline Analysis Population Description
The primary end point of the study was the incidence of grade 3-4 OM according to the WHO scale. Assuming an α = 0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 47 participants 94 participants
55.7  (8.6) 53.5  (6.9) 54.6  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
Female
7
  14.9%
5
  10.6%
12
  12.8%
Male
40
  85.1%
42
  89.4%
82
  87.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 47 participants 47 participants 94 participants
47 47 94
1.Primary Outcome
Title Incidence and / or Severity of Oral Mucositis
Hide 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.
Time Frame 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data related to the primary endpoint were handled in a per protocol treatment analysis.
Arm/Group Title Placebo Low Level Laser Therapy
Hide Arm/Group Description:

Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

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.

The investigators used a 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.

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.

Overall Number of Participants Analyzed 47 47
Measure Type: Number
Unit of Measure: Grade 3-4 oral mucositis
19 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Low Level Laser Therapy
Comments The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.158
Confidence Interval (2-Sided) 95%
0.050 to 0.498
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.
Hide 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.
Time Frame 7 weeks
Outcome Measure Data Not Reported
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Low Level Laser Therapy
Hide Arm/Group Description

Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

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.

The investigators used a 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.

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.

All-Cause Mortality
Placebo Low Level Laser Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Low Level Laser Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/47 (36.17%)      15/47 (31.91%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders  1 [1]  4/47 (8.51%)  4 0/47 (0.00%)  0
Ear and labyrinth disorders     
Ear and labyrinth disorders  1 [1]  3/47 (6.38%)  3 4/47 (8.51%)  4
Infections and infestations     
Pneumonia  1 [2]  1/47 (2.13%)  1 1/47 (2.13%)  1
Renal and urinary disorders     
Renal and urinary disorders  1 [1]  5/47 (10.64%)  5 3/47 (6.38%)  3
Skin and subcutaneous tissue disorders     
Radiodermatitis  1 [3]  4/47 (8.51%)  4 7/47 (14.89%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Unplanned chemotherapy interruptions or modification
[2]
Unplanned radiotherapy interruptions due to pneumonia
[3]
Unplanned radiotherapy interruptions due to radiodermatis: Laser group = 7 patients and Placebo group = 4 patients
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Low Level Laser Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/47 (36.17%)      10/47 (21.28%)    
Gastrointestinal disorders     
Gastrointestinal disorders  1 [1]  17/47 (36.17%)  17 10/47 (21.28%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Distribution of severe oral pain intensity
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Heliton Spindola Antunes
Organization: Instituto Nacional de Cancer
Phone: 55 21 32076597
EMail: hspindola@inca.gov.br
Layout table for additonal information
Responsible Party: Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT01439724    
Other Study ID Numbers: INCABrazil
Protocol 17/2007 ( Registry Identifier: Protocol 17/2007 )
First Submitted: September 20, 2011
First Posted: September 23, 2011
Results First Submitted: March 7, 2014
Results First Posted: April 11, 2014
Last Update Posted: April 11, 2014