NCT06837480

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Lymphedema of the Head and Neck

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-15
• Primary completion: 2029-08-30
• Completion: 2029-11-30
• First posted: 2025-02-20
• Last updated: 2026-01-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study