Photobiomodulation Therapy for Radiation Fibrosis

(PBM-LEF Trial)

Overseen By Cancer Trials Inbox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Photosensitivity, Chronic immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a light therapy called Photobiomodulation (PBM) to determine its effectiveness in reducing the side effects of radiation treatment in individuals with head and neck cancer. These side effects, known as radiation fibrosis syndrome, can include neck pain, difficulty swallowing, and swelling. Participants will receive either the actual PBM treatment or a sham (inactive) treatment for comparison. The study seeks individuals who have undergone radiation for head and neck cancer, are experiencing these side effects, and are currently cancer-free. As an unphased trial, it offers a unique opportunity to explore new methods for alleviating post-radiation side effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive therapies, you may not be eligible to participate.

What prior data suggests that Photobiomodulation Therapy is safe for treating radiation fibrosis syndrome?

Research shows that Photobiomodulation (PBM) therapy is generally well-tolerated. Studies have found that PBM can help reduce side effects of cancer treatments, such as mouth sores and skin irritation. Another study found that PBM might aid cell growth and repair in damaged areas, indicating that PBM is gentle on the body and promotes healing.

Although specific information on its use for radiation fibrosis syndrome (RFS) is limited, available studies suggest it is safe. The reviewed studies have not shown PBM therapy to cause serious side effects, making it a potentially safe option for those dealing with radiation-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Photobiomodulation (PBM) Therapy for radiation fibrosis because it offers a non-invasive approach that uses light to stimulate cellular repair and reduce scarring. Unlike traditional treatments for radiation fibrosis, which often involve medications or surgical interventions, PBM targets cells directly, promoting healing and reducing inflammation naturally. This therapy could provide a more comfortable and accessible option for patients, potentially improving their quality of life without the side effects associated with more invasive procedures.

What evidence suggests that Photobiomodulation Therapy might be an effective treatment for radiation fibrosis?

Research has shown that Photobiomodulation (PBM) therapy might help treat radiation fibrosis syndrome (RFS) in individuals who have undergone radiation therapy for head and neck cancer. PBM therapy uses light to aid healing, and studies suggest it may alleviate symptoms like skin tightness and enhance overall quality of life. In this trial, participants will receive either PBM therapy or a sham treatment. Patients who received PBM treatments experienced fewer and less severe skin problems caused by radiation. Additionally, PBM therapy has been linked to better body image and improved ability to perform daily activities, which can be especially beneficial for those with RFS. Although specific data on RFS is limited, PBM has proven effective in similar conditions, suggesting it could be promising for this use. ^{1 4 6 7 8}

Who Is on the Research Team?

Kenneth S. Hu

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PBM or sham therapy at 12 sites on the neck and face, occurring at two timepoints: 3-18 months and 18-36 months after RT completion

Up to 36 months

Multiple visits as per treatment schedule

Follow-up

Participants are monitored for changes in soft tissue thickness via ultrasound

2 weeks post-treatment

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Photobiomodulation (PBM) Therapy
• Sham PBM

Trial Overview 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.

How Is the Trial Designed?

Group I: Active Treatment: PBM Therapy Experimental Treatment 1 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 Treatment Placebo Group 1 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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study involving 92 patients undergoing post-mastectomy radiation therapy (PMRT) with a hypofractionated regimen of 43.5 Gy over 15 days, the majority experienced mild skin toxicities, with 62% developing grade 2 dermatitis, which mostly resolved within three months.

The hypofractionated approach demonstrated a low incidence of significant acute toxicities, while effectively covering the target areas, although it resulted in a slightly higher dose to the ipsilateral lung compared to the heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy in postmastectomy locally advanced breast cancer: an interim report on acute toxicities and dosimetry. Jamora, K., Cruz-Lim, EM., Cereno, RE., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32460618/

Photobiomodulation Therapy to Mitigate Radiation Fibrosis ... Conclusions: This review summarizes the in vitro data, preclinical animal studies and clinical reports, which showcase the potential benefits of PBM treatments ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842821001372

Effectiveness of photobiomodulation therapy in radiation ... There is very low certainty of evidence that PBMT was effective in the prevention of RD. However, PBMT showed a significant effect to prevent grade 3 RD in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12139614/

Potential role of photobiomodulation as a prevention and ... PBMT offers a promising intervention for managing RIF, with potential to enhance body image, self-confidence, functional abilities, and overall quality of life ...

4. mdpi.com mdpi.com/2304-6732/9/1/10

The Efficacy of Photobiomodulation Therapy in Improving ... We observed that both PBM treatments—red and NIR—demonstrated significantly less incidence and severity and improved healing with skin radionecrosis. Radiation ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-01224

Photobiomodulation with Light-Emitting Diode Therapy for ... Receiving PBM with LED therapy may work well to improve radiation fibrosis syndrome in patients who have undergone radiation for the treatment of head and neck ...

6. liebertpub.com liebertpub.com/doi/full/10.1089/photob.2019.4766?doi=10.1089/photob.2019.4766

Photobiomodulation Therapy to Mitigate Radiation Fibrosis ... This article concluded that PBM treatments increased stem cell survival, proliferation, and homing to sites of injury. Additionally, in their studies, they ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06708754

NCT06708754 | Impact of Photobiomodulation (PBM) on ... Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/php.14107

A comprehensive review of photobiomodulation in cancer ... In summary, PBM therapy can alleviate side effects of cancer treatments such as acute oral mucositis, radiation dermatitis, lymphedema, ...