Photobiomodulation Therapy for Radiation Fibrosis (PBM-LEF Trial)

N/A

Waitlist Available

Led By Kenneth Hu

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2 post-treatment

Summary

This trial aims to compare the effectiveness of Photobiomodulation therapy with a placebo treatment for managing the side effects of radiation therapy in head and neck cancer patients. The study will involve up to

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of PBM are not detailed here, it's generally considered low-risk. Possible side effects may include skin irritation at the site of application.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2 post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 2 post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2 post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

STT at Nodal Level II - Left Side

STT at Nodal Level III - Left Side

STT at Nodal Level III - Right Side

+3 more

Trial Design

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

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