Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study

NCT03738332 | Completed Results FDA Device

• 1 other identifier: UPCC12318
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.

Conditions

Head and Neck Cancer; Lymphedema; Fibrosis

Outcome Measures

Primary Outcomes (4)

• Number of Participants Consented and Enrolled in Study

  Number of participants who consented the study and number of participants who enrolled in the study

  Approximately 5-month recruitment window

• Number of Participants Completed the Study Visits

  Number of participants who completed the study visits

  Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

• Number of Participants With Adverse Events

  Number of participants who experienced adverse events during the course of the study.

  Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

• Number of Participants Who Were Satisfied With Study Intervention.

  Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy).

  at 4-week post-intervention visit

Study Arms (1)

Low-level laser therapy

OTHER

Single arm

Device: Low-Level Laser

Interventions

Low-Level Laser DEVICE

Low-level laser therapy

Low-level laser therapy

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
• Completion of either postoperative radiation or chemoradiation therapy
• No evidence of cancer
• Having head and neck external lymphedema
• Either completion of lymphedema therapy or not in active lymphedema therapy
• Ability to speak and read English
• Able 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; photosensitivity; chronic inflammatory diseases; venous thrombosis; history of severe trauma; medication that affects body fluid and electrolyte balance; use of high doses of non-steroidal anti-inflammatory drugs; or pre-existing skin rash, ulceration, open wound in the treatment area; and allergic and other systemic skin diseases.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Deng J, Lukens JN, Zhu J, Cohn JC, Andersen LP, Spinelli BA, Quinn RJ, Chittams J, McMenamin E, Lin A. Patient Experience of Photobiomodulation Therapy in Head and Neck Chronic Lymphedema. J Palliat Med. 2023 Sep;26(9):1225-1233. doi: 10.1089/jpm.2021.0419. Epub 2023 Apr 28.

  PMID: 37116057 DERIVED

• Deng J, Lukens JN, Swisher-McClure S, Cohn JC, Spinelli BA, Quinn RJ, Chittams J, McMenamin E, Lin A. Photobiomodulation Therapy in Head and Neck Cancer-Related Lymphedema: A Pilot Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211037938. doi: 10.1177/15347354211037938.

  PMID: 34387119 DERIVED

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

jiedeng@nursing.upenn.edu

215-573-2393

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Pre-and post design

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: February 25, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 1, 2022
• Results First Posted: January 25, 2022

Record last verified: 2022-01

Locations

US (1)