NCT06837480 Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
| NCT ID | NCT06837480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2029-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-01-15 with a primary completion date of 2029-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06837480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06837480 currently recruiting?
Yes, NCT06837480 is actively recruiting participants. Contact the research team at jiedeng@nursing.upenn.edu for enrollment information.
Where is the NCT06837480 trial being conducted?
This trial is being conducted at Philadelphia, United States, Nashville, United States.
Who is sponsoring the NCT06837480 clinical trial?
NCT06837480 is sponsored by Abramson Cancer Center at Penn Medicine. The trial plans to enroll 150 participants.
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