Trial Outcomes & Findings for Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (NCT NCT01772706)
NCT ID: NCT01772706
Last Updated: 2026-07-01
Results Overview
The primary outcome is the number of patients with oral mucositis grade ≥2 as assessed by the World Health Organization (WHO) oral mucositis grading scale, reflecting functional impairment in oral intake. Oral mucositis is assessed weekly to evaluate the preventive and therapeutic efficacy of low-level laser therapy in patients undergoing concomitant radiotherapy and chemotherapy for stage III-IV head and neck squamous cell carcinoma.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment
Results posted on
2026-07-01
Participant Flow
Participant milestones
| Measure |
Laser Low-level Energy Functional
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
low level laser therapy
|
Laser Low-level Energy Nonfunctional
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
placebo (laser low level energy nonfunctional)
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
49
|
|
Overall Study
COMPLETED
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Laser Low-level Energy Functional
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
low level laser therapy
|
Laser Low-level Energy Nonfunctional
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
placebo (laser low level energy nonfunctional)
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Laser Low-level Energy Functional
n=42 Participants
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
low level laser therapy
|
Laser Low-level Energy Nonfunctional
n=41 Participants
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
placebo (laser low level energy nonfunctional)
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=42 Participants
|
58 years
n=41 Participants
|
58 years
n=83 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=42 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=42 Participants
|
38 Participants
n=41 Participants
|
75 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatmentThe primary outcome is the number of patients with oral mucositis grade ≥2 as assessed by the World Health Organization (WHO) oral mucositis grading scale, reflecting functional impairment in oral intake. Oral mucositis is assessed weekly to evaluate the preventive and therapeutic efficacy of low-level laser therapy in patients undergoing concomitant radiotherapy and chemotherapy for stage III-IV head and neck squamous cell carcinoma.
Outcome measures
| Measure |
Laser Low-level Energy Functional
n=42 Participants
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
low level laser therapy
|
Laser Low-level Energy Nonfunctional
n=41 Participants
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
placebo (laser low level energy nonfunctional)
|
|---|---|---|
|
Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification
|
16 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Assessment at Week 7, corresponding to the completion of concomitant chemoradiotherapy.Population: Analyses were performed on available data; patients with missing outcome data were not included in the corresponding analysis. No imputation on missing data was provided
Pain intensity is evaluated at the final treatment session using a Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain), with scores categorized as 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain).
Outcome measures
| Measure |
Laser Low-level Energy Functional
n=40 Participants
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
low level laser therapy
|
Laser Low-level Energy Nonfunctional
n=37 Participants
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
placebo (laser low level energy nonfunctional)
|
|---|---|---|
|
Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)
0 (No pain)
|
10 Participants
|
11 Participants
|
|
Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)
1-3 (Mild pain)
|
15 Participants
|
8 Participants
|
|
Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)
4-6 (Moderate pain)
|
9 Participants
|
11 Participants
|
|
Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)
7-10 (Severe pain)
|
6 Participants
|
7 Participants
|
Adverse Events
Laser Low-level Energy Functional
Serious events: 11 serious events
Other events: 23 other events
Deaths: 0 deaths
Laser Low-level Energy Nonfunctional
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Laser Low-level Energy Functional
n=48 participants at risk
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
low level laser therapy
|
Laser Low-level Energy Nonfunctional
n=49 participants at risk
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
placebo (laser low level energy nonfunctional)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumopathy
|
2.1%
1/48 • Number of events 1 • 60 months
|
0.00%
0/49 • 60 months
|
|
General disorders
Hyperthermia
|
2.1%
1/48 • Number of events 1 • 60 months
|
2.0%
1/49 • Number of events 1 • 60 months
|
|
Infections and infestations
Implant site infection
|
0.00%
0/48 • 60 months
|
4.1%
2/49 • Number of events 2 • 60 months
|
|
Infections and infestations
pneumopathy
|
2.1%
1/48 • Number of events 1 • 60 months
|
0.00%
0/49 • 60 months
|
|
Vascular disorders
Hypovolaemic shock
|
2.1%
1/48 • Number of events 1 • 60 months
|
0.00%
0/49 • 60 months
|
|
Injury, poisoning and procedural complications
mucite
|
0.00%
0/48 • 60 months
|
2.0%
1/49 • Number of events 1 • 60 months
|
|
Blood and lymphatic system disorders
Hemorrhage symptom
|
2.1%
1/48 • Number of events 1 • 60 months
|
0.00%
0/49 • 60 months
|
|
Gastrointestinal disorders
aphagia
|
0.00%
0/48 • 60 months
|
2.0%
1/49 • Number of events 1 • 60 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.1%
1/48 • Number of events 1 • 60 months
|
0.00%
0/49 • 60 months
|
|
Renal and urinary disorders
Renal failure
|
6.2%
3/48 • Number of events 3 • 60 months
|
2.0%
1/49 • Number of events 1 • 60 months
|
|
Renal and urinary disorders
Arrest of urinary output
|
2.1%
1/48 • Number of events 1 • 60 months
|
0.00%
0/49 • 60 months
|
|
Nervous system disorders
stroke
|
0.00%
0/48 • 60 months
|
2.0%
1/49 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.1%
1/48 • Number of events 1 • 60 months
|
2.0%
1/49 • Number of events 1 • 60 months
|
Other adverse events
| Measure |
Laser Low-level Energy Functional
n=48 participants at risk
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
low level laser therapy
|
Laser Low-level Energy Nonfunctional
n=49 participants at risk
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
placebo (laser low level energy nonfunctional)
|
|---|---|---|
|
Injury, poisoning and procedural complications
mucositis
|
47.9%
23/48 • Number of events 23 • 60 months
|
36.7%
18/49 • Number of events 18 • 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place