Low-Level Laser in Head and Neck Chronic Lymphedema

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Fibrosis; Lymphedema

• 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.

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-07-18
• Study First Posted: 2020-07-23
• Study Start: 2021-08-19
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-30
• Results First Submitted: 2024-07-18
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Results First Posted: 2024-11-19
• Last Update Posted: 2024-11-19

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

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
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.
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.

Trial Locations

Locations (1)

University of Pennsylvania Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States