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Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

NCT06837480 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2029-08-30
Completion
2029-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06837480 on ClinicalTrials.gov