Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
LTU-904 Portable Laser Therapy Unit (active laser device)
DeviceThe RianCorp LTU-904 laser therapy unit (active laser device) will be used for photobiomodulation therapy (PBMT).
LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)
DeviceThe RianCorp LTU-904 laser therapy (sham/inactive laser device) unit will be used for sham therapy.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: ARM A: PBMT12Active comparator 2 interventions
Group B: ARM B: PBMT18Active comparator 1 intervention
Group C: ARM C: PlaceboSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Severity of External Lymphedema
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.
Time frame
Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-interventionSecondary outcomes
1
Total Severity of Internal Lymphedema
Modified Patterson Scale Endoscopic exams were performed by a trained oncology provider. Internal lymphedema was scored using the Modified Patterson Scale, which documents internal swelling in the oral cavity, pharynx, and larynx. Four grades are used to rate edema level (normal = 0, mild = 1, moderate = 2, and severe = 3) for each anatomical structure. Sites are marked "N/A" when they are unable to be evaluated. The scale has good intra-rater reliability (weighted kappa, 0.84) and moderate inter-rater reliability (weighted kappa, 0.54). 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.
Time frame
Pre-intervention, after 18 sessions (end-of-intervention), 12-month post-intervention2
Symptom Burden Score
Head and Neck Lymphedema and Fibrosis Symptom Inventory 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. Change in symptom burden score from baseline to 12-month post-intervention. A larger reduction in this score means decreased symptom burden.
Time frame
Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention3
Jaw Range of Motion Degree
Jaw Range of Motion Scale Jaw Range of Motion Scale is a validated scale with a ruler in millimeters to measure mouth opening. Change in jaw range of motion degree from baseline to 12-month post-intervention. A larger increase in this degree means better outcome with increased jaw range of motion.
Time frame
Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention4
Neck Range of Motion Degree
Cervical Range of Motion Scale Cervical Range of Motion Device, a valid and reliable tool, will be 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. Change in neck range of motion degree from baseline to 12-month post-intervention. A larger change in this degree means better outcome with increased neck range of motion.
Time frame
Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov