Low-Level Laser in Head and Neck Chronic Lymphedema

NCT04482855 | Completed Results FDA Device

• 1 other identifier: UPCC 01320
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Lymphedema; Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 8-week post-intervention visit

Secondary Outcomes (3)

• Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale

  Baseline, 8-week post-intervention visit

• Neck Range of Motion Degree: Right Lateral Rotation

  Baseline, 8-week post-intervention visit

• Quality of Life Score: Feeding Tube

  Baseline, 8-week post-intervention visit

Study Arms (2)

Group 1 (laser group)

EXPERIMENTAL

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.

Device: Low-level laser

Group 2 (wait-list control group)

NO INTERVENTION

Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group.

Interventions

Low-level laser DEVICE

Low-level laser therapy

Group 1 (laser group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lymphedema; Fibrosis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Dr. Jie Deng
• Organization: University of Pennsylvania School of Nursing

jiedeng@nursing.upenn.edu

2155734729

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Model Details: Randomized, wait-list control

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 23, 2020
• Study Start: August 19, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-10

Locations

US (1)