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NCT04482855 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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