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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of Photobiomodulation Therapy for treating radiation fibrosis?

While there is no direct evidence for Photobiomodulation Therapy in treating radiation fibrosis, research suggests that fibrosis is a dynamic process and may be reversible. Other treatments targeting similar pathways, like antioxidants and cytokines, have shown promise, indicating potential for therapies like Photobiomodulation to be effective. ^{1 2 3 4 5}

How is Photobiomodulation Therapy different from other treatments for radiation fibrosis?

Photobiomodulation Therapy is unique because it uses light to stimulate healing and reduce inflammation, which is different from traditional treatments that may involve medication or surgery. This non-invasive approach can be particularly beneficial for managing radiation fibrosis, where there are limited standard treatment options. ^{6 7 8 9 10}

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.

Research Team

Kenneth S. Hu

Principal Investigator

NYU Langone Health

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.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Hypofractionation of partial breast irradiation using radiobiological models. [2018]

2. Italy pubmed.ncbi.nlm.nih.gov

Impact of dose and volume on subcutaneous fibrosis. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

TGF-beta1 and radiation fibrosis: a master switch and a specific therapeutic target? [2022]

4. England pubmed.ncbi.nlm.nih.gov

Radiation fibrosis--current clinical and therapeutic perspectives. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Peritoneal macrophages mediated delivery of chitosan/siRNA nanoparticle to the lesion site in a murine radiation-induced fibrosis model. [2013]

6. Cyprus pubmed.ncbi.nlm.nih.gov

Assessment of acute toxicities and early local recurrences in post mastectomy breast cancer patients by accelerated hypofractionated radiotherapy; a single arm clinical trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated intensity-modulated radiotherapy for carcinoma of the prostate: analysis of toxicity. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Conventional versus hypofractionated postmastectomy radiotherapy: a report on long-term outcomes and late toxicity. [2020]

9. Poland pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy in postmastectomy locally advanced breast cancer: an interim report on acute toxicities and dosimetry. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Emulsion of Olive Oil and Calcium Hydroxide for the Prevention of Radiation Dermatitis in Hypofractionation Post-Mastectomy Radiotherapy: A Randomized Controlled Trial. [2022]