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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: Recruiting NA study, sponsored by NYU Langone Health.
NCT06708754 is a NA study that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
STT will be measured via ultrasound.
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 |
What NCT06708754 shows while recruiting
NCT06708754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Photobiomodulation (PBM) Therapy is the first listed.
NCT06708754 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06708754's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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