Photobiomodulation for chronic head and neck lymphedema
Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors With Chronic Lymphedema
This will test whether photobiomodulation (low-level laser) can reduce chronic lymphedema in people who were treated for head and neck cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT06837480 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with biopsy-confirmed head and neck cancer who are cancer-free 12–60 months after treatment, have chronic external lymphedema for at least 6 months involving two or more sites with at least one site of moderate severity, and who have not responded to prior lymphedema therapy.
Not a fit: Patients with active cancer, pregnancy or other medical conditions that make photobiomodulation unsafe, those who currently respond well to standard lymphedema care, or those unable to travel to study sites are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this noninvasive laser therapy could reduce swelling, improve neck and facial function, and enhance quality of life for survivors with chronic lymphedema.
How similar studies have performed: Previous pilot trials in head and neck cancer survivors demonstrated feasibility, acceptability, and preliminary efficacy, and photobiomodulation is already FDA-approved for breast cancer–related arm lymphedema.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania and 1 other locations
- University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Jie Deng, PhD
- Email: jiedeng@nursing.upenn.edu
- Phone: 2155732393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.