Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Device: 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).
  • Device: 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.
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).
  • Device: 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).
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).
  • Device: 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.

Recruiting Locations

University of Pennsylvania Abramson Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Jie Deng, PhD

More Details

Status
Recruiting
Sponsor
Abramson Cancer Center at Penn Medicine

Study Contact

Jie Deng, PhD
2155732393
jiedeng@nursing.upenn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.