Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

NCT ID: NCT06837480

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2029-11-30

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.

Conditions

Head and Neck Cancer; Lymphedema of the Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ARM A: PBMT12

After completion of the baseline measures, participants in ARM A will be scheduled for PBMT twice a week for 6 weeks followed by sham therapy once per week for 6 weeks (a total of 18 sessions: 12 PBMT and 6 sham therapy sessions).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

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

ARM B: PBMT18

After completion of the baseline measures, participants in ARM B will be scheduled for PBMT twice a week for 6 weeks followed by PBMT once per week for 6 weeks (a total of 18 PBMT sessions).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

ARM C: Placebo

After completion of the baseline measures, participants in ARM C will receive sham therapy, twice a week for 6 weeks followed by sham therapy once per week for 6 weeks (a total of 18 sham therapy sessions).

Group Type: SHAM_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

>18 years of age Biopsy proven head and neck cancer No evidence of cancer at the time of study enrollment, between 12- and 60-month post-cancer treatment Chronic lymphedema (defined as lymphedema persisting for a minimum of 6 months) A minimum of 2 sites of external lymphedema At least 1 site with lymphedema of moderate severity as assessed using the HN-LEF Assessment Criteria Failed lymphedema therapy (defined as any of the following: incomplete response to therapy, progression of lymphedema after therapy, inability to perform effective self-care resulting in fluid re-accumulation; and inability to complete treatment due to systems barriers). In addition, patients must be able to understand English in order to complete questionnaires; and to provide informed consent.

Exclusion Criteria

Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of PBMT:

Women of childbearing age and potential Acute cellulitis within the soft tissues in the head and neck region Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis Requiring ongoing use of diuretics and corticosteroids Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema or physical therapy (including hyperbaric oxygen or trental) Allergic and other systemic skin diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jie Deng

Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Jie Deng, PhD

Role: CONTACT

jiedeng@nursing.upenn.edu

2155732393

Sarah Latimore, MS

Role: CONTACT

2155732393

Facility Contacts

Jie Deng, PhD

Role: primary

Barbara Murphy, MD

Role: primary

Other Identifiers

Pending

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 01325

Identifier Type: -

Identifier Source: org_study_id