Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation (PBM) Therapy
DevicePBM 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
DeviceSham PBM will be delivered using a matching shame device that emits no output power.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active Treatment: PBM TherapyExperimental treatment 1 intervention
Group B: Sham TreatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Soft tissue thickness (STT) at Nodal Level II - Right Side
STT will be measured via ultrasound.
Time frame
Baseline, Week 2 Post-Treatment2
STT at Nodal Level II - Left Side
STT will be measured via ultrasound.
Time frame
Baseline, Week 2 Post-Treatment3
STT at Nodal Level III - Right Side
STT will be measured via ultrasound.
Time frame
Baseline, Week 2 Post-Treatment4
STT at Nodal Level III - Left Side
STT will be measured via ultrasound.
Time frame
Baseline, Week 2 Post-TreatmentSponsors and contacts
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Source ClinicalTrials.gov