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

Not Applicable

Completed

• Conditions: Fibrosis; Head and Neck Cancer; Lymphedema
• Interventions: Device: Low-Level Laser

• Registration Number: NCT03738332
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-13
• Study Start: 2019-02-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Results First Submitted: 2021-11-14
• Results First Submitted QC: 2021-12-29
• Status Verified: 2022-01
• Results First Posted: 2022-01-25
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-level laser therapy	Low-Level Laser	Single arm

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Were Satisfied With Study Intervention.	at 4-week post-intervention visit	Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy).
Number of Participants Completed the Study Visits	Approximately 10 weeks, from baseline visit to 4-week post-intervention visit	Number of participants who completed the study visits
Number of Participants With Adverse Events	Approximately 10 weeks, from baseline visit to 4-week post-intervention visit	Number of participants who experienced adverse events during the course of the study.
Number of Participants Consented and Enrolled in Study	Approximately 5-month recruitment window	Number of participants who consented the study and number of participants who enrolled in the study

Trial Locations

Locations (1)

University of Pennsylvania Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States