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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738332
• Other study ID #: UPCC12318
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Head and Neck Cancer
• Lymphedema

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
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Consented and Enrolled in Study	Number of participants who consented the study and number of participants who enrolled in the study	Approximately 5-month recruitment window
Primary	Number of Participants Completed the Study Visits	Number of participants who completed the study visits	Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Primary	Number of Participants With Adverse Events	Number of participants who experienced adverse events during the course of the study.	Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Primary	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).	at 4-week post-intervention visit