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Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

Recruiting

Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors With Chronic Lymphedema

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.

What is being tested

Sponsor: Abramson Cancer Center at Penn Medicine · Participants: 150 · Started: Jan 15, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT06837480

Locations in the U.S.

PennsylvaniaUniversity of Pennsylvania Abramson Cancer Center, Philadelphia
TennesseeVanderbilt University Medical Center, Nashville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.