Trial Outcomes & Findings for Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients (NCT NCT01439724)
NCT ID: NCT01439724
Last Updated: 2014-04-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
94 participants
Primary outcome timeframe
7 weeks
Results posted on
2014-04-11
Participant Flow
Participant milestones
| Measure |
Placebo
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.
|
Low Level Laser Therapy
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.
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|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
|
Overall Study
COMPLETED
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Placebo
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.
|
Low Level Laser Therapy
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.
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|---|---|---|
|
Overall Study
missing consultation
|
9
|
8
|
Baseline Characteristics
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=47 Participants
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.
|
Low Level Laser Therapy
n=47 Participants
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.
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Total
n=94 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
55.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
47 participants
n=5 Participants
|
47 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Data related to the primary endpoint were handled in a per protocol treatment analysis.
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.
Outcome measures
| Measure |
Placebo
n=47 Participants
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.
|
Low Level Laser Therapy
n=47 Participants
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.
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|---|---|---|
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Incidence and / or Severity of Oral Mucositis
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19 Grade 3-4 oral mucositis
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3 Grade 3-4 oral mucositis
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SECONDARY outcome
Timeframe: 7 weeksOral 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.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 17 serious events
Other events: 17 other events
Deaths: 0 deaths
Low Level Laser Therapy
Serious events: 15 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
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.
|
Low Level Laser Therapy
n=47 participants at risk
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.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Radiodermatitis
|
8.5%
4/47 • Number of events 4 • 3 years
|
14.9%
7/47 • Number of events 7 • 3 years
|
|
Infections and infestations
Pneumonia
|
2.1%
1/47 • Number of events 1 • 3 years
|
2.1%
1/47 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders
|
10.6%
5/47 • Number of events 5 • 3 years
|
6.4%
3/47 • Number of events 3 • 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
6.4%
3/47 • Number of events 3 • 3 years
|
8.5%
4/47 • Number of events 4 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
8.5%
4/47 • Number of events 4 • 3 years
|
0.00%
0/47 • 3 years
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
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.
|
Low Level Laser Therapy
n=47 participants at risk
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.
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|---|---|---|
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Gastrointestinal disorders
Gastrointestinal disorders
|
36.2%
17/47 • Number of events 17 • 3 years
|
21.3%
10/47 • Number of events 10 • 3 years
|
Additional Information
Dr. Heliton Spindola Antunes
Instituto Nacional de Cancer
Phone: 55 21 32076597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place