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 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. Al

Trial Details

NCT ID
NCT06708754
Phase
NA
Sponsor
NYU Langone Health
Status
RECRUITING
Cancer Type
Salivary Gland Head and Neck Cancer
Interventions
  • Photobiomodulation (PBM) Therapy
  • Sham PBM
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Patients treated with radiation for head and neck cancer who are ≥ 3 months \< 36 months post-RT (last RT).
  • Patients who received at least 50Gy of bilateral neck RT. Subjects who received RT or concurrent chemoradiation (chemoRT) therapy for HNC are eligi…
  • No evidence of disease as documented by imaging 3 months after completion of RT.
  • Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment.

For full eligibility, visit ClinicalTrials.gov.

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