Actively Recruiting
Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
Led by NYU Langone Health · Updated on 2026-03-30
60
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated with radiation for head and neck cancer who are 63 3 months and < 36 months post-radiation
- Patients who received at least 50Gy of bilateral neck radiation therapy
- Patients who received radiation or concurrent chemoradiation therapy for head and neck cancer
- No evidence of disease as shown by imaging 3 months after radiation completion
- Fibrosis score of 2 or greater at enrollment
- Patient willing to comply with all study procedures and available for study duration
You will not qualify if you...
- Women who are pregnant, planning to become pregnant, or breastfeeding
- Patients enrolled in another drug or device trial for prevention or treatment of lymphedema or fibrosis
- Patients deprived of freedom, under supervision, or guardianship
- Patients unable to attend scheduled visits due to geographical, social, or mental reasons
- Patients who received prior photobiomodulation therapy for radiation toxicities in the last year
- Patients who report being photosensitive
- Patients with chronic immunosuppression or on current immunosuppressive therapies
- Patients unlikely to comply fully with study requirements as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
K
Kenneth Hu
CONTACT
C
Cancer Trials Inbox
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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