Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study

University of Pennsylvania

Status: Completed

Conditions: Lymphedema; Fibrosis; Head and Neck Cancer

Treatments: Device: Low-Level Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03738332

UPCC12318

Details and patient eligibility

About

The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.

Full description

Primary aim:

To determine the feasibility of the use of LLLT for HNC survivors with lymphedema, specifically to 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years of age
• Completion of either postoperative radiation or chemoradiation therapy
• No evidence of cancer
• Having head and neck external lymphedema
• Either completion of lymphedema therapy or not in active lymphedema therapy
• Ability to speak and read English
• Able 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 LLLT: pregnancy; photosensitivity; chronic inflammatory diseases; venous thrombosis; history of severe trauma; medication that affects body fluid and electrolyte balance; use of high doses of non-steroidal anti-inflammatory drugs; or pre-existing skin rash, ulceration, open wound in the treatment area; and allergic and other systemic skin diseases.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Low-level laser therapy

Other group

Description:

Single arm

Treatment:

Device: Low-Level Laser