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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT06708754 · 19-00511

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗