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RECRUITING
NCT06837480
NA

Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-01-15

Completion Date

2029-11-30

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DEVICE

LTU-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).

DEVICE

LTU-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