Recruiting

PBMT

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06837480

Conditions

Head and Neck Cancer

Lymphedema of the Head and Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LTU-904 Portable Laser Therapy Unit (active laser device)

LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)

Study Details

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.

Conditions

Head and Neck Cancer

Lymphedema of the Head and Neck

Study ID

NCT06837480

Start date

Jan 15, 2026

Status verified date

Jun, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Aug 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

LTU-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).

LTU-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.

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 and Locations

Central contacts

Jie Deng, PhD

2155732393jiedeng@nursing.upenn.edu

Sarah Latimore, MS

2155732393

Locations

University of Pennsylvania Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Head and neck cancer, chronic lymphedema, photobiomodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-06-23.