University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT04482855
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in severity of lymphedema.
Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT:
Low-level laser therapy
Time frame: Baseline, 8-week post-intervention visit
Head and Neck Lymphedema and Fibrosis Assessment Criteria
Change in total severity of external LEF from baseline to 8-week post-intervention visits. A larger change in this score means more reduction in the severity of external LEF.
External LEF is measured by HN-LEF Assessment Criteria. The total external LEF 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 LEF (=0), mild (=1), moderate (=2), and severe (=3).
Time frame: Baseline, 8-week post-intervention visit
Head and Neck Lymphedema and Fibrosis Symptom Inventory
Change in symptom burden score from baseline to 8-week post-intervention. A larger change in this score means decreased symptom burden.
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. There are 7 subscales and only one subscale (Soft Tissues and Neurologic Toxicity) score is reported here.
Time frame: Baseline, 8-week post-intervention visit
Change in neck range of motion degree from baseline to 8-week post-intervention. A larger change in this degree means better outcome with increased neck range of motion.
Cervical Range of Motion Device, a valid and reliable tool, was 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. Only right lateral rotation is reported here.
Time frame: Baseline, 8-week post-intervention visit
EORTC QLQ-H&N35 was used to assess HNC-related quality of life.
Change in EORTC QLQ-H&N35 score from baseline to 8-week post-intervention. A larger reduction in this score means decreased symptom burden and better quality of life.
The HNC-specific EORTC QLQ-H&N35 module is a supplement, containing seven multi-item scales (pain, swallowing, senses problems, speech problems, trouble with social eating and social contact, and less sexuality) and eleven single-item scales (teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain). The QLQ-H&N35 scale employs a 4-point response format (''not at all" to ''very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the symptoms scales, a higher score indicates a higher level of symptom burden. Only feeding tube scale is reported here.
Abramson Cancer Center at Penn Medicine
Other
Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial
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