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 (ESMULLLAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03955224|
Recruitment Status : Not yet recruiting
First Posted : May 20, 2019
Last Update Posted : August 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Upper Aerodigestive Tract Neoplasms||Device: Basic Oral Care + active LLLT Other: Basic oral Care + inactive LLLT Other: Basic Oral Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
|Active Comparator: Basic Oral Care + active LLLT (experimental arm)||
Device: Basic Oral Care + active LLLT
|Placebo Comparator: Basic oral Care + inactive LLLT (control arm)||
Other: Basic oral Care + inactive LLLT
|Basic Oral Care (control arm)||
Other: Basic Oral Care
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955224
|Contact: Emmanuelle VIGARIOS||05 31 15 53 email@example.com|
|Institut Universitaire du Cancer de Toulouse - Oncopole||Not yet recruiting|
|Contact: Emmanuelle VIGARIOS 05 31 15 53 74 firstname.lastname@example.org|