Low-Level Laser in Head and Neck Chronic Lymphedema

Not Applicable

Completed

Conditions: Head and Neck Cancer
Fibrosis
Lymphedema

Interventions: Device: Low-level laser

Registration Number: NCT04482855

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (laser group)	Low-level laser	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.

Primary Outcome Measures

Name	Time	Method
Total Severity of External Lymphedema and Fibrosis (LEF)	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).

Secondary Outcome Measures

Name	Time	Method
Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale	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.
Neck Range of Motion Degree: Right Lateral Rotation	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.
Quality of Life Score: Feeding Tube	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.