Back to resultsLow-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
Primary Purpose
Head and Neck Cancer, Lymphedema, Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Level Laser
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
Eligibility Criteria
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.
Sites / Locations
- University of Pennsylvania Abramson Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Low-level laser therapy
Arm Description
Single arm
Outcomes
Primary Outcome Measures
Number of Participants Consented and Enrolled in Study
Number of participants who consented the study and number of participants who enrolled in the study
Number of Participants Completed the Study Visits
Number of participants who completed the study visits
Number of Participants With Adverse Events
Number of participants who experienced adverse events during the course of the study.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03738332
First Posted
November 8, 2018
Last Updated
January 25, 2022
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03738332
Brief Title
Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
Official Title
Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Lymphedema, Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-and post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-level laser therapy
Arm Type
Other
Arm Description
Single arm
Intervention Type
Device
Intervention Name(s)
Low-Level Laser
Intervention Description
Low-level laser therapy
Primary Outcome Measure Information:
Title
Number of Participants Consented and Enrolled in Study
Description
Number of participants who consented the study and number of participants who enrolled in the study
Time Frame
Approximately 5-month recruitment window
Title
Number of Participants Completed the Study Visits
Description
Number of participants who completed the study visits
Time Frame
Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Title
Number of Participants With Adverse Events
Description
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
Title
Number of Participants Who Were Satisfied With Study Intervention.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34387119
Citation
Deng J, Lukens JN, Swisher-McClure S, Cohn JC, Spinelli BA, Quinn RJ, Chittams J, McMenamin E, Lin A. Photobiomodulation Therapy in Head and Neck Cancer-Related Lymphedema: A Pilot Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211037938. doi: 10.1177/15347354211037938.
Results Reference
derived
Learn more about this trial
Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
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