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Completed

NCT Number: NCT03738332

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

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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Key information

Conditions

Head and Neck Cancer Fibrosis Head and Neck Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-level laser

Device

Low-level laser therapy

Primary outcomes

  1. Number of Participants Consented and Enrolled in Study

    Time frame: Approximately 5-month recruitment window

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

  2. Number of Participants Completed the Study Visits

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

    Number of participants who completed the study visits

  3. Number of Participants With Adverse Events

    Time frame: 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.

  4. Number of Participants Who Were Satisfied With Study Intervention.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2018
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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