CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Low Level Laser Therapydevice
Likely dose
Low-level laser therapy delivered 3 times per week concurrently with chemoradiotherapy via THOR® LED cluster for 1 minute along buccal mucosa extra-orallyAI-extracted
Key inclusion· 4
  • ✓Biopsy-proven head and neck cancer (nasopharynx, oropharynx, larynx, hypopharynx, or unknown primary) planned for definitive or adjuvant radiotherapy with concurrent chemotherapy
  • ✓Planned continuous course of IMRT/IGRT at 5000-7000 cGy in single daily fractions of 180-200 cGy with concurrent weekly or tri-weekly cisplatin or carboplatin
  • ✓Karnofsky performance status > 60
  • ✓Age ≥ 18 years
Key exclusion· 10
  • ✕Prior radiation to the head and neck
  • ✕Evidence of current mucositis, mucosal ulceration, or unhealed surgical wounds from resection or biopsy
  • ✕Gross tumor involvement of the oral cavity or oral mucosa
  • ✕Planned altered fractionation radiotherapy or multiple fractions per day

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

Search/NCT02723604
NCT02723604N/ACompleted
CompareCT.gov

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

Barbara Ann Karmanos Cancer Institute·interventional·Posted Mar 30, 2016·Updated Feb 27, 2023

In Brief

A clinical study evaluating Low Level Laser Therapy for Mucositis. Completed, enrolled 25 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
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 30, 2016
Enrollment StartMar 1, 2016
Primary CompletionAug 2, 2017
Study CompletionSep 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.3 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.