RecruitingNot ApplicableNCT06837480

Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

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


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

150 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests photobiomodulation therapy — the use of low-level laser or light — to treat chronic lymphedema of the head and neck that persists after cancer treatment. Lymphedema causes painful, persistent swelling that can significantly affect swallowing, speech, and quality of life. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with head and neck cancer (confirmed by biopsy) - You show no signs of active cancer at time of enrollment, and it has been 12 to 60 months since completing cancer treatment - You have chronic lymphedema (swelling that has persisted for at least 6 months) affecting at least 2 external sites - At least one area of swelling is moderate or severe - Prior lymphedema therapy has not fully resolved your symptoms - You can understand English and provide informed consent **You may NOT be eligible if...** - Your lymphedema is recent (less than 6 months) - You have active cancer - You do not meet the criteria for failed prior therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELTU-904 Portable Laser Therapy Unit (active laser device)

The RianCorp LTU-904 laser therapy unit (active laser device) will be used for photobiomodulation therapy (PBMT).

DEVICELTU-904 Portable Laser Therapy Unit (sham/inactive laser device)

The RianCorp LTU-904 laser therapy (sham/inactive laser device) unit will be used for sham therapy.


Locations(2)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT06837480


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