N/A
N=25
Low-Level Laser in Head and Neck Chronic Lymphedema
Head and Neck Cancer · Lymphedema · Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT04482855 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Total Severity of External Lymphedema and Fibrosis (LEF) — 5.42; 4.08; 3.22; 4.62 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low-level laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Severity of External Lymphedema and Fibrosis (LEF) |
5.42; 4.08; 3.22; 4.62 | — |
| SECONDARY Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale |
2.46; 1.63; 1.73; 1.23 | — |
| SECONDARY Neck Range of Motion Degree: Right Lateral Rotation |
45.38; 48.04; 52.78; 47.85 | — |
| SECONDARY Quality of Life Score: Feeding Tube |
16.67; 15.38; 0; 7.69 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04482855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.