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Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors With Chronic Lymphedema

NCT ID: NCT06837480Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2026-01-21

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.

Arms & interventions

  • DeviceLTU-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).

  • DeviceLTU-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.

Outcome measures

Primary

  • 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.

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

Secondary

  • Total Severity of Internal Lymphedema

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

  • Symptom Burden Score

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

  • Jaw Range of Motion Degree

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

  • Neck Range of Motion Degree

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

  • Shoulder Range of Motion Degree

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

  • Quality of Life Score

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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (2)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Recruiting
Jie Deng, PhD · Contact

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Not Yet Recruiting
Barbara Murphy, MD · Contact
Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema | Cancerify