Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT06837480
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Jan 2026
Primary completion
Aug 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ARM A: PBMT12
    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).
  • Active Comparator: ARM B: PBMT18
    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).
  • Sham Comparator: ARM C: Placebo
    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).

Primary Outcome Measure

Total 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104
Jie Deng, PhD
Vanderbilt University Medical CenterNashvilleTennessee37232
Barbara Murphy, MD

Find similar trials in Philadelphia, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Pennsylvania Abramson Cancer Center· Philadelphia, PAVanderbilt University Medical Center· Nashville, TN

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