Trial · NCT07899866
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Grade 2 or Higher Radiation Dermatitis Assessed by NCI-CTCAE v5.0 | From the first to the last radiotherapy session, approximately 7 weeks | Occurrence of radiation dermatitis of grade 2 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (moderate to brisk erythema, moist desquamation mostly confined to skin folds and/or moderate edema, or worse), assessed at each PBM session (3 times per week). Clinical, demographic, tumor-related, treatment-related and PBM-related factors associated with this outcome will be identified by univariate analyses and multivariable logistic regression. |
| Secondary | Number of Participants With Grade 3 or Higher Radiation Dermatitis Assessed by NCI-CTCAE v5.0 | From the first to the last radiotherapy session, approximately 7 weeks | Occurrence of severe radiation dermatitis (grade 3 or higher according to NCI-CTCAE version 5.0), assessed at each PBM session (3 times per week). |
| Secondary | Time to Onset of the First Grade 2 or Higher Radiation Dermatitis | From the start of radiotherapy to the first grade 2 or higher radiation dermatitis, assessed up to the end of radiotherapy (approximately 7 weeks) | Time in days between the start of radiotherapy and the first radiation dermatitis of grade 2 or higher (NCI-CTCAE v5.0). Participants without the event are censored at the end of follow-up. |
| Secondary | Duration of Grade 2 or Higher Radiation Dermatitis | From the first grade 2 or higher radiation dermatitis to return to grade lower than 2, assessed up to the end of radiotherapy (approximately 7 weeks) | Time in days between the date of the first radiation dermatitis of grade 2 or higher (NCI-CTCAE v5.0) and the date of return to a grade lower than 2 (or disappearance of clinical signs as documented). |
| Secondary | Number of Participants With an Unplanned Radiotherapy Interruption of at Least 5 Consecutive Days Attributable to Radiation Dermatitis | From the first to the last radiotherapy session, approximately 7 weeks | Unplanned interruption of radiotherapy lasting 5 or more consecutive days attributable to radiation dermatitis (yes/no). |
| Secondary | Number of Participants With a Radiotherapy Dose Reduction of at Least 10% Attributable to Radiation Dermatitis | From the first to the last radiotherapy session, approximately 7 weeks | Reduction of the radiotherapy dose of 10% or more attributable to radiation dermatitis (yes/no). |
| Secondary | Number of Participants With at Least One Postponed Radiotherapy Session Attributable to Radiation Dermatitis | From the first to the last radiotherapy session, approximately 7 weeks | At least one radiotherapy session postponed because of radiation dermatitis (yes/no). |
| Secondary | Number of Participants With at Least One Adverse Event Related or Possibly Related to PBM | From the first to the last PBM session, approximately 7 weeks | Adverse events related or possibly related to photobiomodulation, collected during and after each PBM session (expected events include local discomfort, sensation of heat, tingling/paresthesia, transient post-PBM erythema, local skin dryness and pruritus). |
| Secondary | Number of PBM-Related Adverse Events by Type | From the first to the last PBM session, approximately 7 weeks | Descriptive typology of adverse events related or possibly related to photobiomodulation (e.g. local discomfort, sensation of heat, tingling, transient erythema, local skin dryness, pruritus), as collected during and after each PBM session. |
| Secondary | Number of PBM-Related Adverse Events by Severity Assessed by NCI-CTCAE v5.0 | From the first to the last PBM session, approximately 7 weeks | Severity of adverse events related or possibly related to photobiomodulation, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, as collected during and after each PBM session. |
| Secondary | Handgrip Strength | At inclusion (before radiotherapy) and at the end of radiotherapy (approximately 7 weeks) | Maximal handgrip strength (kg) measured with a hydraulic dynamometer. Higher values indicate greater strength. The association between handgrip strength and the presence of grade 2 or higher radiation dermatitis will be explored. |
| Secondary | Number of Chair Rises in the 1-Minute Sit-to-Stand Test | At inclusion (before radiotherapy) and at the end of radiotherapy (approximately 7 weeks) | Number of sit-to-stand repetitions performed in 60 seconds. Higher values indicate better functional capacity. The association with the presence of grade 2 or higher radiation dermatitis will be explored. |
| Secondary | Number of Participants With Malnutrition According to HAS Criteria | At inclusion, during radiotherapy and at the end of radiotherapy (approximately 7 weeks) | Malnutrition diagnosed according to the French National Authority for Health (HAS 2019 for adults under 70 years, HAS 2021 for adults 70 years or older) criteria: at least one phenotypic criterion and at least one etiological criterion; severity graded as moderate or severe. The association with the presence of grade 2 or higher radiation dermatitis will be explored. |
| Secondary | Pain Intensity Assessed by Visual Analog Scale | At inclusion, at each PBM session during radiotherapy and at the end of radiotherapy (approximately 7 weeks) | Pain intensity on a visual analog scale (VAS) from 0 (no pain) to 10 (worst pain); higher scores indicate more pain. The association with the presence of grade 2 or higher radiation dermatitis will be explored. |
| Secondary | Number of Participants Using Opioid Analgesics | From the first to the last radiotherapy session, approximately 7 weeks | Use of opioid analgesics (yes/no). The association with the presence of grade 2 or higher radiation dermatitis will be explored. |
| Secondary | EORTC QLQ-H&N35 Scores at the End of Radiotherapy | At the end of radiotherapy (week 6 to 7) | Total score and relevant subscales (swallowing, mouth pain, dry mouth, mouth opening) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck module (QLQ-H\&N35). Items are scored from 1 to 4 and transformed to 0-100 scales according to the EORTC scoring manual; higher scores indicate a higher level of symptoms. Scores will be compared between participants with and without grade 2 or higher radiation dermatitis. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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