Trial Summary
What is the purpose of 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 is for head and neck cancer patients who have undergone radiation therapy and are experiencing symptoms like swelling, difficulty in opening the mouth, neck pain, or issues with speech and swallowing due to radiation fibrosis syndrome.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.
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Participant Groups
The study compares Photobiomodulation (PBM) Therapy using LED lights against a sham treatment to see if PBM can reduce tissue thickness associated with chronic inflammation from radiation therapy in these patients.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment: PBM TherapyExperimental Treatment1 Intervention
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
Group II: Sham TreatmentPlacebo Group1 Intervention
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor