NCT03955224

Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Study in Patients With Upper Aerodigestive Tract Cancer

Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Phase II Randomized Study in Patients With Upper Aerodigestive Tract Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy. Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment. The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days. Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.

Conditions

• Upper Aerodigestive Tract Neoplasms

Interventions

Type	Name	Description
DEVICE	Basic Oral Care + active LLLT	* Compliance with the Basic Oral Care Associated with * Active LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)
OTHER	Basic oral Care + inactive LLLT	* Compliance with the Basic Oral Care Associated with * Inactive LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)
OTHER	Basic Oral Care	Compliance with the Basic Oral Care only

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2019-05-20
• Last updated: 2021-04-08

Locations

1 site across 1 country: France