Low-Level Laser in Head and Neck Chronic Lymphedema

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Lymphedema; Fibrosis; Head and Neck Cancer

Treatments: Device: Low-level laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04482855

UPCC 01320

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.

Full description

Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in severity of lymphedema.

Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years of age
• >6 months post HNC treatment
• No evidence of cancer confirmed with imaging tests
• Having head and neck lymphedema with or without fibrosis
• Completion of initial lymphedema therapy
• Lymphedema duration between 3-24 months
• Ability to speak and read English
• Ability 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
• Acute infection
• Photosensitivity
• Chronic inflammatory diseases
• Venous thrombosis
• Carotid artery stenosis
• History of severe trauma
• Medication that affects body fluid and electrolyte balance
• Use of high doses of non-steroidal anti-inflammatory drugs
• Pre-existing skin rash, ulceration, open wound in the treatment area
• Active lymphedema therapy or physical therapy
• Allergic and other systemic skin diseases

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Group 1 (laser group)

Experimental group

Description:

Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection.

Treatment:

Device: Low-level laser

Group 2 (wait-list control group)

No Intervention group

Description:

Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group.