Recruiting
NA
INTERVENTIONAL
NCT06837480
Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
LTU-904 Portable Laser Therapy Unit (active laser device)
Type:
DEVICE
Description:
The RianCorp LTU-904 laser therapy unit (active laser device) will be used for photobiomodulation therapy (PBMT).
Name:
LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)
Type:
DEVICE
Description:
The RianCorp LTU-904 laser therapy (sham/inactive laser device) unit will be used for sham therapy.
Primary Outcomes
Measure:
Total Severity of External Lymphedema
TimeFrame:
Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Description:
Head and Neck Lymphedema and Fibrosis Assessment Criteria.
External lymphedema is measured by HN-LEF Assessment Criteria. The total external lymphedema severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no lymphedema (=0), mild (=1), moderate (=2), and severe (=3).
Change in total severity of external lymphedema from baseline to 12-month post-intervention visits. A larger reduction in this score means more reduction in the severity of external lymphedema.
Trial Information
NCT ID
NCT06837480
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Abramson Cancer Center at Penn Medicine
Last Updated
December 15, 2025