CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
Low Level Laser Therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02682992
NCT02682992N/ACompleted

A Phase II Prospective Trial of Low-Level Laser Therapy for Prevention of Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

David A. Clump, MD, PhD·interventional·Posted Feb 17, 2016·Updated Apr 13, 2022

In Brief

A clinical study evaluating Low Level Laser Therapy for Mucositis. Completed, enrolled 47 participants across 1 site.

Detailed Summary

The overall purpose of this study is to examine the efficacy of prophylactic low-level laser therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients receiving combined modality therapy consisting of chemotherapy and radiation therapy for head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucositis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 17, 2016
Enrollment StartJun 1, 2016
Primary CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 10.4 years ago

Interventions

Low Level Laser Therapydevice

Patients will receive LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam will be performed to identify any areas of mucositis. If the patient should develop intraoral lesions they will be targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings to be used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.