Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

Abramson Cancer Center at Penn Medicine

Status: Not yet enrolling

Conditions: Head and Neck Cancer; Lymphedema of the Head and Neck

Treatments: Device: LTU-904 Portable Laser Therapy Unit (sham/inactive laser device); Device: LTU-904 Portable Laser Therapy Unit (active laser device)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06837480

Pending

UPCC 01325

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

ARM A: PBMT12

Active Comparator group

Description:

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).

Treatment:

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

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

ARM B: PBMT18

Active Comparator group

Description:

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).

Treatment:

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

ARM C: Placebo

Sham Comparator group

Description:

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).

Treatment:

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