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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06837480.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Jie Deng
Phone: 215-573-2393
PRIMARY OBJECTIVE:
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
Principal InvestigatorJie Deng