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NCT06708754 · ClinicalTrials.gov registry record · NA
Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
A NA study, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT06708754 is a NA study that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 60 participants.
The verdict
NCT06708754, a NA study, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ dysfunction. Some of the side effects that encompass RFS in the head and neck (HNC) population include decreased ability to fully open the mouth (trismus), neck pain and tightness (cervical dystonia), lymphedema (swelling), difficult with speech and swallowing and salivary hypofunction. Although there is Level I evidence demonstrating the benefit of Photobiomodulation (PBM) therapy to prevent acute mucositis in HNC patients treated with RT, there is only limited data regarding its impact. This is a clinical trial to compare active treatment (PBM-therapy) with sham control (Sham- therapy). Up to 60 patients will be randomized to the two groups with equal allocation to estimate the efficacy (soft tissue thickness) of external Photobiomodulation (PBM) with light-emitting diode (LED) planned therapy for the treatment of radiation fibrosis syndrome (RFS) in head and neck cancer (HNC) patients who have undergone radiation therapy (RT) compared with sham control.
Interventions
- DEVICE Photobiomodulation (PBM) Therapy
- DEVICE Sham PBM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-02-13 |
| Est. Completion | 2030-02-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06708754
The ClinicalTrials.gov registry entry for NCT06708754 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Photobiomodulation (PBM) Therapy is the first listed.
NCT06708754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06708754 about?
NCT06708754 is a clinical study titled "Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients". Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy ...
What is the current status of trial NCT06708754?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-02-13. Estimated completion is 2030-02-13.
What interventions are being tested in trial NCT06708754?
The interventions under investigation include: Photobiomodulation (PBM) Therapy (DEVICE), Sham PBM (DEVICE).
Who is sponsoring clinical trial NCT06708754?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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