Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Cancer; Lymphedema of the Head and Neck

• Registration Number: NCT06837480
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-15
• Study First Posted: 2025-02-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-22
• Study Start: 2025-07-15
• Primary Completion: 2029-08-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Severity of External Lymphedema	Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Total Severity of Internal Lymphedema	Pre-intervention, after 18 sessions (end-of-intervention), 12-month post-intervention	Modified Patterson Scale; Endoscopic exams were performed by a trained oncology provider. Internal lymphedema was scored using the Modified Patterson Scale, which documents internal swelling in the oral cavity, pharynx, and larynx. Four grades are used to rate edema level (normal = 0, mild = 1, moderate = 2, and severe = 3) for each anatomical structure. Sites are marked "N/A" when they are unable to be evaluated. The scale has good intra-rater reliability (weighted kappa, 0.84) and moderate inter-rater reliability (weighted kappa, 0.54).; 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.
Symptom Burden Score	Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention	Head and Neck Lymphedema and Fibrosis Symptom Inventory; Symptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden.; Change in symptom burden score from baseline to 12-month post-intervention. A larger reduction in this score means decreased symptom burden.
Jaw Range of Motion Degree	Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention	Jaw Range of Motion Scale; Jaw Range of Motion Scale is a validated scale with a ruler in millimeters to measure mouth opening.; Change in jaw range of motion degree from baseline to 12-month post-intervention. A larger increase in this degree means better outcome with increased jaw range of motion.
Neck Range of Motion Degree	Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention	Cervical Range of Motion Scale; Cervical Range of Motion Device, a valid and reliable tool, will be used to measure the amount of neck movement (degrees) for the following neck movements: forward flexion, extension, right and left lateral flexion, and right and left rotation.; Change in neck range of motion degree from baseline to 12-month post-intervention. A larger change in this degree means better outcome with increased neck range of motion.
Shoulder Range of Motion Degree	Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention	Goniometry; Goniometry is a validated and reliable tool for measuring shoulder range of motion.; Change in shoulder range of motion degree from baseline to 12-month post-intervention. A larger change in this degree means better outcome with increased shoulder range of motion.
Quality of Life Score	Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention	Quality of Life Scale (Linear Analog Self-Assessment, LASA); Quality of Life Scale (Linear Analog Self-Assessment, LASA) has been extensively used in cancer (e.g., HNC) patients. The scale has shown good reliability (alpha=.83-.88) and good concurrent/construct validity. It covers four major components of QOL (i.e., physical, emotional, spiritual, and intellectual).; Change in quality of life score from baseline to 12-month post-intervention. A larger increase in this score means better quality of life.

Trial Locations

Locations (2)

University of Pennsylvania Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States