Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients (PBM-LEF)

PBM-LEF Study: The Impact of PBM on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients: A Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Radiation Fibrosis; Radiation Lymphedema
• Intervention / Treatment: Device: Photobiomodulation (PBM) Therapy; Device: Sham PBM

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth Hu; Phone Number: 212-731-5880; Email: Kenneth.Hu@nyulangone.org
• Study Contact Backup: Name: Cancer Trials Inbox; Email: CancerTrials@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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 eligible.
• 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.
• Patient who has body mass index (BMI) >30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis.
• Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

• Woman who are pregnant or planning to become pregnant or breast-feeding.
• Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF.
• Patients deprived of freedom, under supervision or guardianship.
• Patients unable to attend to scheduled visits due to geographical, social or mental reasons.
• Patients who received prior PBM therapy for RT toxicities in the last year;
• Patients who report being photosensitive.
• Patients who have chronic immunosuppression or are on current immunosuppressive therapies.
• Any patient who, in the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment: PBM Therapy; Participants who received bilateral neck RT will be treated with PBM to a total of 12 sites - 6 sites on each side of the neck and face along the 3 neck nodal levels (II, III, IV) of the sternocleidomastoid muscle (SCM), along the major salivary glands (parotid, and submandibular) and masseter]. Treatment will occur at two timepoints: At least 3 months and less than 18 months after RT completion of last dose to any site; Between 18 and 36 months after RT completion of last dose to any site	Device: Photobiomodulation (PBM) Therapy; PBM is a low-intensity form of light therapy and employs visible or near-infrared (NIR) light generated from a laser or Light Emitting Diode (LED). In this study, PBM will be delivered using an LED device emitting 660 and 850nm with the purpose of research. The output power typically ranges from 5 to 200 mW with wavelengths ranging 600-1,000nm.
Sham Comparator: Sham Treatment; Participants who received bilateral neck RT will be treated with SHAM PBM to a total of 12 sites - 6 sites on each side of the neck and face along the 3 neck nodal levels (II, III, IV) of the sternocleidomastoid muscle (SCM), along the major salivary glands (parotid, and submandibular) and masseter]. Treatment will occur at two timepoints: At least 3 months and less than 18 months after RT completion of last dose to any site; Between 18 and 36 months after RT completion of last dose to any site	Device: Sham PBM; Sham PBM will be delivered using a matching shame device that emits no output power.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue thickness (STT) at Nodal Level II - Right Side	STT will be measured via ultrasound.	Baseline, Week 2 Post-Treatment
STT at Nodal Level II - Left Side	STT will be measured via ultrasound.	Baseline, Week 2 Post-Treatment
STT at Nodal Level III - Right Side	STT will be measured via ultrasound.	Baseline, Week 2 Post-Treatment
STT at Nodal Level III - Left Side	STT will be measured via ultrasound.	Baseline, Week 2 Post-Treatment
STT at Nodal Level IV - Right Side	STT will be measured via ultrasound.	Baseline, Week 2 Post-Treatment
STT at Nodal Level IV - Left Side	STT will be measured via ultrasound.	Baseline, Week 2 Post-Treatment

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Kenneth Hu, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): February 13, 2028
• Study Completion (Estimated): February 13, 2030

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Radiation Injuries; Fibrosis; Pathological Conditions, Signs and Symptoms; Radiation Fibrosis Syndrome; Head and Neck Neoplasms; Laser Therapy; Phototherapy; Therapeutics; Low-Level Light Therapy
• Other Study ID Numbers: 19-00511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No