Low-Level Laser in Head and Neck Chronic Lymphedema

Abramson Cancer Center at Penn Medicine25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer Lymphedema Fibrosis

Interventions

Low-level laserDEVICE

Low-level laser therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Total Severity of External Lymphedema and Fibrosis (LEF)

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

Secondary Outcomes

Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale

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

Neck Range of Motion Degree: Right Lateral Rotation

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

Quality of Life Score: Feeding Tube

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.

Data from ClinicalTrials.gov

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