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Photobiomodulation for Radiation Lymphedema and Fibrosis in Head and Neck Cancer

This study is looking at how a light therapy called Photobiomodulation (PBM) might help with side effects like swelling (lymphedema) and stiffness (fibrosis) that can happen after radiation treatment for head and neck cancer. PBM uses low-intensity light, similar to a laser or LED, to treat these issues. We are testing PBM against a 'sham' treatment, which looks the same but doesn't deliver any light. The study aims to see if PBM can reduce the thickness of soft tissues in the neck, which is a sign of lymphedema and fibrosis. You might be able to join if you are an adult who had radiation for head and neck cancer at least 3 months but less than 3 years ago, and received a certain amount of radiation to both sides of your neck, with no current signs of cancer. We plan to enroll 60 participants, but the current recruitment status is unclear.

Study design
This is an interventional study with 60 planned participants, comparing Photobiomodulation (PBM) therapy to a sham device.
What's involved
The primary endpoints, measuring soft tissue thickness, are taken at baseline and two weeks post-treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for at least two weeks post-treatment, based on the primary endpoint timeframes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06708754

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

Recruiting
NAAges 18+InterventionalTreatment
NYU Langone Health
~60 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Photobiomodulation (PBM) TherapySham PBM

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Soft tissue thickness (STT) at Nodal Level II - Right Side
Measured over Baseline, Week 2 Post-Treatment
+5 more outcomes measured

Conditions

Radiation Lymphedema
Radiation Fibrosis
Head and Neck Cancer

Explore related trials

Lymphedema due to radiationMalignant Head and Neck NeoplasmRadiation Fibrosis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Kenneth Hu · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Kenneth Hu
[email protected]
212-731-5880
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Soft tissue thickness (STT) at Nodal Level II - Right SideBaseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  • STT at Nodal Level II - Left SideBaseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  • STT at Nodal Level III - Right SideBaseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  • STT at Nodal Level III - Left SideBaseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  • STT at Nodal Level IV - Right SideBaseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  • STT at Nodal Level IV - Left SideBaseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.