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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer Lymphedema Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-and post design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Low-level laser therapy

Single arm

Group Type OTHER

Low-Level Laser

Intervention Type DEVICE

Low-level laser therapy

Interventions

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Low-Level Laser

Low-level laser therapy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No