Low-Level Laser in Head and Neck Chronic Lymphedema

Head and Neck Cancer Clinical Trial

Official title:

Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482855
• Other study ID #: UPCC 01320
• Status: Completed
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Head and Neck Cancer
• Lymphedema

Intervention

Device:
• Low-level laser
Low-level laser therapy

Locations

Country	Name	City	State
United States	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with reduced severity of lymphedema and fibrosis	Head and Neck Lymphedema and Fibrosis Assessment Criteria	Up to 8-week post-LLLT
Secondary	Symptom burden score	Head and Neck Lymphedema and Fibrosis Symptom Inventory	Up to 8-week post-LLLT
Secondary	Neck range of motion degree	Cervical Range of Motion Device	Up to 8-week post-LLLT
Secondary	Quality of life score	EORTC QLQ-H&N35	Up to 8-week post-LLLT