Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

NCT06837480 | Recruiting DMC FDA Device

• 2 other identifiers: UPCC 01325Pending
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Keywords

Head and neck cancer, chronic lymphedema, photobiomodulation

Outcome Measures

Primary Outcomes (1)

• Total Severity of External Lymphedema

  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.

  Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention

Secondary Outcomes (6)

• Total Severity of Internal Lymphedema

  Pre-intervention, after 18 sessions (end-of-intervention), 12-month post-intervention

• Symptom Burden Score

  Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention

• Jaw Range of Motion Degree

  Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention

• Neck Range of Motion Degree

  Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention

• Shoulder Range of Motion Degree

  Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention

Study Arms (3)

ARM A: PBMT12

ACTIVE COMPARATOR

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).

Device: LTU-904 Portable Laser Therapy Unit (active laser device); Device: LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)

ARM B: PBMT18

ACTIVE COMPARATOR

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).

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

ARM C: Placebo

SHAM COMPARATOR

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).

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

Interventions

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

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

ARM A: PBMT12; ARM B: PBMT18

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

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

ARM A: PBMT12; ARM C: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (2)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Jie Deng, PhD

CONTACT

2155732393; jiedeng@nursing.upenn.edu

Sarah Latimore, MS

CONTACT

2155732393

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): August 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)