NCT03738332

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

Completed NA Results posted Last updated 1 February 2022

What this trial tests

NA trial testing Low-Level Laser in Head and Neck Cancer in 12 participants. Completed in 31 December 2020.

Timeline

25 February 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	12
Start date	25 February 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Low-Level Laser

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Lymphedema — all drugs for Lymphedema →
• Fibrosis — all drugs for Fibrosis →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Head and Neck Cancer or Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Consented and Enrolled in Study Primary · Approximately 5-month recruitment window

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

Group	Value	95% CI
Low-level Laser Therapy	12

Number of Participants Completed the Study Visits Primary · Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

Number of participants who completed the study visits

Group	Value	95% CI
Low-level Laser Therapy	11

Number of Participants With Adverse Events Primary · Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

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

Group	Value	95% CI
Low-level Laser Therapy	0

Number of Participants Who Were Satisfied With Study Intervention. Primary · at 4-week post-intervention visit

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

Group	Value	95% CI
Low-level Laser Therapy	11

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Photobiomodulation Therapy in Head and Neck Cancer-Related Lymphedema: A Pilot Feasibility Study.
   Deng J, Lukens JN, Swisher-McClure S, Cohn JC, et al · · 2021 · cited 14× · PMID 34387119 · DOI 10.1177/15347354211037938
2. Patient Experience of Photobiomodulation Therapy in Head and Neck Chronic Lymphedema.
   Deng J, Lukens JN, Zhu J, Cohn JC, et al · · 2023 · cited 3× · PMID 37116057 · DOI 10.1089/jpm.2021.0419