Recruiting

PBM Therapy

Sponsor:

NYU Langone Health

Code:

NCT06708754

Conditions

Radiation Lymphedema

Radiation Fibrosis

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photobiomodulation (PBM) Therapy

Sham PBM

Study Details

Brief summary:

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

Radiation Lymphedema

Radiation Fibrosis

Head and Neck Cancer

Study ID

NCT06708754

Start date

Feb 13, 2025

Status verified date

Mar, 2026

Completion date

Feb 13, 2030

Anticipated

Primary completion date

Feb 13, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

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 PBM

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

Primary outcome measure

  • Soft tissue thickness (STT) at Nodal Level II - Right Side [ Time Frame: Baseline, Week 2 Post-Treatment ]
  • STT at Nodal Level II - Left Side [ Time Frame: Baseline, Week 2 Post-Treatment ]
  • STT at Nodal Level III - Right Side [ Time Frame: Baseline, Week 2 Post-Treatment ]
  • STT at Nodal Level III - Left Side [ Time Frame: Baseline, Week 2 Post-Treatment ]
  • STT at Nodal Level IV - Right Side [ Time Frame: Baseline, Week 2 Post-Treatment ]
  • STT at Nodal Level IV - Left Side [ Time Frame: Baseline, Week 2 Post-Treatment ]

Central Contacts and Locations

Central contacts

Kenneth Hu

212-731-5880Kenneth.Hu@nyulangone.org

Cancer Trials Inbox

CancerTrials@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-30.