Low-Level Laser in Head and Neck Chronic Lymphedema
Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Abramson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 (laser group)
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.
|
Low-level laser therapy
|
|
No Intervention: Group 2 (wait-list control group)
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Severity of External Lymphedema and Fibrosis (LEF)
Time Frame: Baseline, 8-week post-intervention visit
|
Head and Neck Lymphedema and Fibrosis Assessment Criteria Change in total severity of external LEF from baseline to 8-week post-intervention visits. A larger change in this score means more reduction in the severity of external LEF. External LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3). |
Baseline, 8-week post-intervention visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale
Time Frame: Baseline, 8-week post-intervention visit
|
Head and Neck Lymphedema and Fibrosis Symptom Inventory Change in symptom burden score from baseline to 8-week post-intervention. A larger change in this score means decreased symptom burden. Symptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden. There are 7 subscales and only one subscale (Soft Tissues and Neurologic Toxicity) score is reported here. |
Baseline, 8-week post-intervention visit
|
|
Neck Range of Motion Degree: Right Lateral Rotation
Time Frame: Baseline, 8-week post-intervention visit
|
Change in neck range of motion degree from baseline to 8-week post-intervention. A larger change in this degree means better outcome with increased neck range of motion. Cervical Range of Motion Device, a valid and reliable tool, was used to measure the amount of neck movement (degrees) for the following neck movements: forward flexion, extension, right and left lateral flexion, and right and left rotation. Only right lateral rotation is reported here. |
Baseline, 8-week post-intervention visit
|
|
Quality of Life Score: Feeding Tube
Time Frame: Baseline, 8-week post-intervention visit
|
EORTC QLQ-H&N35 was used to assess HNC-related quality of life. Change in EORTC QLQ-H&N35 score from baseline to 8-week post-intervention. A larger reduction in this score means decreased symptom burden and better quality of life. The HNC-specific EORTC QLQ-H&N35 module is a supplement, containing seven multi-item scales (pain, swallowing, senses problems, speech problems, trouble with social eating and social contact, and less sexuality) and eleven single-item scales (teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain). The QLQ-H&N35 scale employs a 4-point response format (''not at all" to ''very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the symptoms scales, a higher score indicates a higher level of symptom burden. Only feeding tube scale is reported here. |
Baseline, 8-week post-intervention visit
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 01320
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.