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Low-Level Laser in Head and Neck Chronic Lymphedema

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
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years of age
  • >6 months post HNC treatment
  • No evidence of cancer confirmed with imaging tests
  • Having head and neck lymphedema with or without fibrosis
  • Completion of initial lymphedema therapy
  • Lymphedema duration between 3-24 months
  • Ability to speak and read English
  • Ability 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
  • Acute infection
  • Photosensitivity
  • Chronic inflammatory diseases
  • Venous thrombosis
  • Carotid artery stenosis
  • History of severe trauma
  • Medication that affects body fluid and electrolyte balance
  • Use of high doses of non-steroidal anti-inflammatory drugs
  • Pre-existing skin rash, ulceration, open wound in the treatment area
  • Active lymphedema therapy or physical therapy
  • Allergic and other systemic skin diseases

Sites / Locations

  • University of Pennsylvania Abramson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1 (laser group)

Group 2 (wait-list control group)

Arm Description

Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection.

Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group.

Outcomes

Primary Outcome Measures

% of patients with reduced severity of lymphedema and fibrosis
Head and Neck Lymphedema and Fibrosis Assessment Criteria

Secondary Outcome Measures

Symptom burden score
Head and Neck Lymphedema and Fibrosis Symptom Inventory
Neck range of motion degree
Cervical Range of Motion Device
Quality of life score
EORTC QLQ-H&N35

Full Information

First Posted
June 24, 2020
Last Updated
July 26, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04482855
Brief Title
Low-Level Laser in Head and Neck Chronic Lymphedema
Official Title
Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

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 study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.
Detailed Description
Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in severity of lymphedema. Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.

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
Parallel Assignment
Model Description
Randomized, wait-list control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (laser group)
Arm Type
Experimental
Arm Description
Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection.
Arm Title
Group 2 (wait-list control group)
Arm Type
No Intervention
Arm Description
Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group.
Intervention Type
Device
Intervention Name(s)
Low-level laser
Intervention Description
Low-level laser therapy
Primary Outcome Measure Information:
Title
% of patients with reduced severity of lymphedema and fibrosis
Description
Head and Neck Lymphedema and Fibrosis Assessment Criteria
Time Frame
Up to 8-week post-LLLT
Secondary Outcome Measure Information:
Title
Symptom burden score
Description
Head and Neck Lymphedema and Fibrosis Symptom Inventory
Time Frame
Up to 8-week post-LLLT
Title
Neck range of motion degree
Description
Cervical Range of Motion Device
Time Frame
Up to 8-week post-LLLT
Title
Quality of life score
Description
EORTC QLQ-H&N35
Time Frame
Up to 8-week post-LLLT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years of age >6 months post HNC treatment No evidence of cancer confirmed with imaging tests Having head and neck lymphedema with or without fibrosis Completion of initial lymphedema therapy Lymphedema duration between 3-24 months Ability to speak and read English Ability 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 Acute infection Photosensitivity Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis History of severe trauma Medication that affects body fluid and electrolyte balance Use of high doses of non-steroidal anti-inflammatory drugs Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema therapy or physical therapy 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

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Low-Level Laser in Head and Neck Chronic Lymphedema

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