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

University of Pennsylvania12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer Lymphedema Fibrosis

Interventions

Low-Level LaserDEVICE

Low-level laser therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of Participants Consented and Enrolled in Study

Number of participants who consented the study and number of participants who enrolled in the study

Time frame: Approximately 5-month recruitment window

Number of Participants Completed the Study Visits

Number of participants who completed the study visits

Time frame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

Number of Participants With Adverse Events

Number of participants who experienced adverse events during the course of the study.

Time frame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

Number of Participants Who Were Satisfied With Study Intervention.

Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy).

Time frame: at 4-week post-intervention visit

Data from ClinicalTrials.gov

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