TriangleNCT01772706 · OUTCOME
Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment
What was measured
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.
Groups in this outcome
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)
| Group | Source count |
|---|---|
| Laser Low-level Energy Functional | 42 |
| Laser Low-level Energy Nonfunctional | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Laser Low-level Energy Functional | 16 | Not reported | Not reported | Not reported | Not reported |
| Laser Low-level Energy Nonfunctional | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- 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.
- groups
- description
- 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
- id
- OG000
- title
- Laser Low-level Energy Functional
- description
- 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)
- id
- OG001
- title
- Laser Low-level Energy Nonfunctional
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment
- title
- Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice