Photobiomodulation for chronic head and neck lymphedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who are cancer-free 12–60 months after treatment for biopsy-confirmed head and neck cancer and who have chronic external lymphedema will receive either an active LTU-904 portable laser device or a sham inactive device. The trial builds on prior pilot work and uses HN-LEF criteria to document at least two sites of external lymphedema with one site of moderate severity. Outcomes will track changes in lymphedema severity, functional measures, and patient-reported symptoms over the treatment period. The intervention targets patients who have not responded to prior lymphedema therapy and requires in-person visits at participating centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\>18 years of age Biopsy proven head and neck cancer No evidence of cancer at the time of study enrollment, between 12- and 60-month post-cancer treatment Chronic lymphedema (defined as lymphedema persisting for a minimum of 6 months) A minimum of 2 sites of external lymphedema At least 1 site with lymphedema of moderate severity as assessed using the HN-LEF Assessment Criteria Failed lymphedema therapy (defined as any of the following: incomplete response to therapy, progression of lymphedema after therapy, inability to perform effective self-care resulting in fluid re-accumulation; and inability to complete treatment due to systems barriers). In addition, patients must be able to understand English in order to complete questionnaires; and to provide informed consent.

Exclusion Criteria:

Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of PBMT:

Women of childbearing age and potential Acute cellulitis within the soft tissues in the head and neck region Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis Requiring ongoing use of diuretics and corticosteroids Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema or physical therapy (including hyperbaric oxygen or trental) Allergic and other systemic skin diseases

Where it's running

• University of Pennsylvania Abramson Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Jie Deng, PhD
• Email: jiedeng@nursing.upenn.edu
• Phone: 2155732393

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)

  This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.

  Recruiting Phase 2 Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07919444

• Airway ultrasound in head and neck cancer patients

  This observational study tests whether neck ultrasound measurements of the airway match CT measurements in adults with maxillofacial cancer undergoing surgery with anesthesia.

  Recruiting at 2 sites University Hospital Dubrava · Zagreb, City of Zagreb and 1 other locations · NCT07910149

• Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia

  This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.

  Recruiting at 2 sites Phase 1 Rockefeller University · Minneapolis, Minnesota and 1 other locations · NCT07901959

• Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer

  In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07882888

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• Using Silverlon for head and neck patients with tracheostomies

  This early-phase study tests whether Silverlon dressings can prevent severe skin reactions under tracheostomy collars in adults with head and neck cancer.

  Recruiting Phase 1 State University of New York - Upstate Medical University · Syracuse, New York · NCT07856732

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.