Trial · NCT07899866
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
NCT07899866, Not yet recruiting, Hopital Forcilles
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation. Trials, record NCT07899866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07899866
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
- NCT number
- NCT07899866
- Status
- Not yet recruiting
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Hopital Forcilles
- Conditions
- Head and Neck Neoplasms, Radiodermatitis
- Interventions
- Preventive photobiomodulation, External beam radiotherapy, Functional, quality-of-life and photographic assessments
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07899866
GET https://conductscience.org/api/trials/v1/NCT07899866/registered