New York, NYNCT06708754Now EnrollingIRB Ready

Radiation Lymphedema Clinical Trial in New York, NY

Access cutting-edge radiation lymphedema treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by NYU Langone Health

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Expert Care in New York

Access radiation lymphedema specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related radiation lymphedema treatment provided free

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Check if you qualify for this radiation lymphedema clinical trial in New York, NY

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Radiation Lymphedema Study in New York

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.

Sponsor: NYU Langone Health

Who Can Participate

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.
Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment.
Patient who has body mass index (BMI) \>30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis.
Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

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.
Patients who received prior PBM therapy for RT toxicities in the last year;
Patients who report being photosensitive.
Patients who have chronic immunosuppression or are on current immunosuppressive therapies.
Any patient who, in the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06708754) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Radiation Lymphedema Treatment Options in New York, NY

If you're searching for radiation lymphedema treatment options in New York, NY, this clinical trial (NCT06708754) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced radiation lymphedema specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all radiation lymphedema clinical trials near you to find additional studies recruiting in your area.

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