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NCT Number: NCT06708754

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. 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.

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Key information

Conditions

Radiation Lymphedema Fibrosis Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Fibrosis Radiation Fibrosis Syndrome Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photobiomodulation (PBM) Therapy

Device

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 PBM

Device

Sham PBM will be delivered using a matching shame device that emits no output power.

Primary outcomes

  1. Soft tissue thickness (STT) at Nodal Level II - Right Side

    Time frame: Baseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  2. STT at Nodal Level II - Left Side

    Time frame: Baseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  3. STT at Nodal Level III - Right Side

    Time frame: Baseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  4. STT at Nodal Level III - Left Side

    Time frame: Baseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  5. STT at Nodal Level IV - Right Side

    Time frame: Baseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

  6. STT at Nodal Level IV - Left Side

    Time frame: Baseline, Week 2 Post-Treatment

    STT will be measured via ultrasound.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Trials Inbox

CONTACT

[email protected]

Kenneth Hu

CONTACT

[email protected]

212-731-5880

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Acronym: PBM-LEF

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Nov 27, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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