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

NCT06708754 | Recruiting FDA Device

• 1 other identifier: 19-00511
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Head and Neck Cancer; Radiation Lymphedema; Radiation Fibrosis

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Active Treatment: PBM Therapy

EXPERIMENTAL

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

Sham Treatment

SHAM COMPARATOR

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

Interventions

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.

Active Treatment: PBM Therapy

Sham PBM DEVICE

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

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Radiation Fibrosis Syndrome; Head and Neck Neoplasms

Interventions

Low-Level Light Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Laser Therapy; Phototherapy

Study Officials

• Kenneth Hu

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Hu

CONTACT

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

Cancer Trials Inbox

CONTACT

CancerTrials@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 27, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): February 13, 2028
• Study Completion (Estimated): February 13, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)