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Recruiting NCT06837480

Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

No phase Interventional Head and Neck Cancer Lymphedema of the Head and Neck

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LTU-904 Portable Laser Therapy Unit (active laser device), LTU-904 Portable Laser Therapy Unit (sham/inactive laser device).
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Lymphedema of the Head and Neck. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors With Chronic Lymphedema

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Total Severity of Internal Lymphedema [Time frame: Pre-intervention, after 18 sessions (end-of-intervention), 12-month post-intervention]
  • Symptom Burden Score [Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention]
  • Jaw Range of Motion Degree [Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention]
  • Neck Range of Motion Degree [Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention]
  • Shoulder Range of Motion Degree [Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention]
  • Quality of Life Score [Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Pennsylvania Abramson Cancer Center — Philadelphia
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT06837480 · UPCC 01325 · Pending

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗