Photobiomodulation for Head and Neck Cancer-Related Lymphedema
This study is investigating if photobiomodulation therapy (PBMT), using the RianCorp LTU-904 Portable Laser Therapy Unit, can help treat chronic lymphedema (swelling) in the head and neck for people who have had head and neck cancer. You may be able to join if you are over 18, have had head and neck cancer, and have chronic lymphedema that has lasted at least 6 months and affects at least two areas, with at least one being moderately severe. The researchers will measure the severity of your external lymphedema to see if the treatment is successful. The study aims to enroll 150 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 150 participants. It will compare an active laser device to a sham (inactive) laser device.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3, 6, 9, and 12 months after the intervention ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Total Severity of External LymphedemaPre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Head and Neck Lymphedema and Fibrosis Assessment Criteria. External lymphedema is measured by HN-LEF Assessment Criteria. The total external lymphedema 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 lymphedema (=0), mild (=1), moderate (=2), and severe (=3). Change in total severity of external lymphedema from baseline to 12-month post-intervention visits. A larger reduction in this score means more reduction in the severity of external lymphedema.