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Low-Level Laser in Head and Neck Chronic Lymphedema
N/A
Waitlist Available
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8-week post-intervention visit
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing low-level laser treatment (LLLT) on head and neck cancer survivors who have lymphedema. LLLT uses light to reduce swelling and improve blood flow, which may help with symptoms like tightness and limited movement. The study aims to see if LLLT can improve their quality of life. Low-level laser therapy (LLLT) has been studied for its effects on reducing inflammation, promoting tissue repair, and relieving pain in various conditions, including breast cancer-related lymphedema.
Eligible Conditions
- Lymphedema
- Head and Neck Cancers
- Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8-week post-intervention visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8-week post-intervention visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total Severity of External Lymphedema and Fibrosis (LEF)
Secondary study objectives
Neck Range of Motion Degree: Right Lateral Rotation
Quality of Life Score: Feeding Tube
Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 (laser group)Experimental Treatment1 Intervention
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 II: Group 2 (wait-list control group)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-level laser
2020
N/A
~230
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
464,097 Total Patients Enrolled
3 Trials studying Lymphedema
564 Patients Enrolled for Lymphedema
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,727,023 Total Patients Enrolled
3 Trials studying Lymphedema
371 Patients Enrolled for Lymphedema