A Phase 2 interventional study of Basic Oral Care + active LLLT and Basic oral Care + inactive LLLT in Upper Aerodigestive Tract Neoplasms, sponsored by Institut Claudius Regaud. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Institut Claudius Regaud · Phase 2, Interventional, and Treatment
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
Browse Head and Neck Neoplasms studies →Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Device: Basic Oral Care + active LLLT
Other: Basic oral Care + inactive LLLT
Other: Basic Oral Care
* Compliance with the Basic Oral Care Associated with * Active LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)
* Compliance with the Basic Oral Care Associated with * Inactive LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)
Compliance with the Basic Oral Care only
Rate of patients who didn't need a dose increase or introduction of new analgesics for mouth pain during the study compared to baseline
Time frame: 16 days for each patient
Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores
Time frame: 16 days for each patient
Quality of Life assessed by the Quality of Life Questionnaire specific to Head and Neck cancer (H&N35)
Time frame: 16 days for each patient
Frequency of adverse events related to the LLLT using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 5.0
Time frame: 16 days for each patient
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Institut Claudius Regaud