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Photobiomodulation Therapy for the Treatment of Lymphedema in Head and Neck Cancer Survivors
Trial Status: active
This clinical trial evaluates the effectiveness of photobiomodulation therapy (PBMT) for treating chronic lymphedema in head and neck cancer survivors. Head and neck cancer survivors may experience multiple symptoms after treatment, including lymphedema, which can impact physical, emotional, and social well-being. Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling. PBMT is a form of light therapy that utilizes lasers in the visible and near-infrared electromagnetic spectrum. It is a non-thermal process that can reduce pain and inflammation and speed healing by altering cellular processes. PBMT has been approved for treating lymphedema in breast cancer survivors and may also be an effective treatment option for head and neck cancer survivors.
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 months 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 Head and Neck - External Lymphedema and Fibrosis (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)
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 for head and neck edema; or pre-existing skin rash, ulceration, open wound in the treatment area; active lymphedema or physical therapy (including hyperbaric oxygen) for head and neck lymphedema and fibrosis); and allergic and other systemic skin diseases
* Rational for exclusion of women of childbearing age and potential: Head and neck cancer is more common in men than in women. Furthermore, the average age of diagnosis of head and neck cancer is between 55 and 65 years. We will exclude women of childbearing age and potential due to the challenges of monitoring pregnancy over the protracted period of study conduct. Specifically, woman who are post-menopausal for > 1 year or status post hysterectomy will be considered candidates
Acute infection: Individuals with a diagnosis of acute cellulitis within the soft tissue in the head and neck region will be excluded from the study until such time as the infection resolves
Patients requiring ongoing use of diuretics and corticosteroids for head and neck edema will be excluded
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06837480.
I. Compare the effects of PBMT12 (12 PBMT sessions), PBMT18 (18 PBMT sessions), and placebo (18 sham therapy sessions) on external lymphedema severity (primary outcome) and internal lymphedema severity.
SECONDARY OBJECTIVE:
I. Compare the effects of PBMT12 (12 PBMT sessions), PBMT18 (18 PBMT sessions), and placebo (18 sham therapy sessions) on lymphedema and fibrosis (LEF)-related symptom burden (e.g., dysphagia), functional impairments (jaw/neck/shoulder range of motion), and quality of life (QOL).
TERTIARY OBJECTIVE:
I. Collect and biobank peripheral blood samples for future analysis if we observe improvement in chronic lymphedema and associated symptom burden and/or functionality.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A: Patients undergo PBMT with the active LTU-904 Portable Laser Therapy Unit over 25-30 minutes twice a week (BIW) for 6 weeks followed by sham PBMT with the sham LTU-904 Portable Laser Therapy Unit once a week (QW) for 6 weeks for a total of 18 sessions over 12 weeks. Patients also undergo collection of blood samples throughout the trial.
ARM B: Patients undergo PBMT with the active LTU-904 Portable Laser Therapy Unit over 25-30 minutes BIW for 6 weeks and then QW for 6 weeks for a total of 18 sessions over 12 weeks. Patients also undergo collection of blood samples throughout the trial.
ARM C: Patients undergo sham PBMT with the sham LTU-904 Portable Laser Therapy Unit over 25-30 minutes BIW for 6 weeks and then QW for 6 weeks for a total of 18 sessions over 12 weeks. Patients also undergo collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
