Low-Level Laser in Head and Neck Chronic Lymphedema

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

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.

Study Overview

• Status: Completed
• Conditions: Fibrosis; Head and Neck Cancer; Lymphedema
• Intervention / Treatment: Device: Low-level laser

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Deng, PhD; Phone Number: 215-573-2393; Email: jiedeng@nursing.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Abramson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (laser group); 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.	Device: Low-level laser; Low-level laser therapy
No Intervention: Group 2 (wait-list control group); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients with reduced severity of lymphedema and fibrosis	Head and Neck Lymphedema and Fibrosis Assessment Criteria	Up to 8-week post-LLLT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom burden score	Head and Neck Lymphedema and Fibrosis Symptom Inventory	Up to 8-week post-LLLT
Neck range of motion degree	Cervical Range of Motion Device	Up to 8-week post-LLLT
Quality of life score	EORTC QLQ-H&N35	Up to 8-week post-LLLT

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 18, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: UPCC 01320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes