Clinical trial · Interventional
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
NCT04482855CI-TRIAL-00082721completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibrosis | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-level laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (laser group)
- 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.
- interventionNames
- Device: Low-level laser
- type
- NO_INTERVENTION
- label
- Group 2 (wait-list control group)
- 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.
Primary outcomes (1)
- measure
- Total Severity of External Lymphedema and Fibrosis (LEF)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDeng J, Lukens JN, Murphy BA, McMenamin E, Rajasekaran K, Quinn RJ, Cohn JC, Schlessinger W, Andersen LP, Spinelli BA, Lin A. Photobiomodulation in Treatment of Head and Neck Cancer-Related Chronic Lymphedema: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261439138. doi: 10.1177/15347354261439138. Epub 2026 May 3. PMID 42071320