Back to resultsEvaluation 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)
Primary Purpose
Upper Aerodigestive Tract Neoplasms
Status
Withdrawn
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Basic Oral Care + active LLLT
Basic oral Care + inactive LLLT
Basic Oral Care
Sponsored by
About this trial
This is an interventional treatment trial for Upper Aerodigestive Tract Neoplasms focused on measuring Upper Aerodigestive Tract Neoplasms, Low-Level Laser Therapy (LLLT), Mucositis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- Patients with upper aero-digestive tract cancer receiving a first cervicofacial radiotherapy or chemoradiotherapy
- Patients with a grade 2 mucositis (according to the NCI CTCAE version 5.0) appearing during treatment.
- Patients available to perform the LLLT treatment: 5 visits at 3 days intervals
- Patients must provide written informed consent prior to any study specific procedures.
- Patients affiliated to a Social Health Insurance in France.
Exclusion Criteria:
- Patients who have already received a cervicofacial radiotherapy
- Patients who have already received an induction chemotherapy for their upper aero-digestive tract cancer
- Patients under targeted therapy for their upper aero-digestive tract cancer
- Patients under systemic corticotherapy
- Patients with a non-grade 2 mucositis (according to the NCI CTCAE version 5.0)
- Patients with ulceration or any other oral mucosa pathology than mucositis
- Pregnant or breastfeeding women
- Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Sites / Locations
- Institut Universitaire du Cancer de Toulouse - Oncopole
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Other
Arm Label
Basic Oral Care + active LLLT (experimental arm)
Basic oral Care + inactive LLLT (control arm)
Basic Oral Care (control arm)
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients who didn't need a dose increase or introduction of new analgesics for mouth pain during the study compared to baseline
Secondary Outcome Measures
Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores
Quality of Life assessed by the Quality of Life Questionnaire specific to Head and Neck cancer (H&N35)
Frequency of adverse events related to the LLLT using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03955224
Brief Title
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
Acronym
ESMULLLAT
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn due to lack of recruitment
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Aerodigestive Tract Neoplasms
Keywords
Upper Aerodigestive Tract Neoplasms, Low-Level Laser Therapy (LLLT), Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Basic Oral Care + active LLLT (experimental arm)
Arm Type
Active Comparator
Arm Title
Basic oral Care + inactive LLLT (control arm)
Arm Type
Placebo Comparator
Arm Title
Basic Oral Care (control arm)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Basic Oral Care + active LLLT
Intervention Description
Compliance with the Basic Oral Care Associated with
Active LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)
Intervention Type
Other
Intervention Name(s)
Basic oral Care + inactive LLLT
Intervention Description
Compliance with the Basic Oral Care Associated with
Inactive LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)
Intervention Type
Other
Intervention Name(s)
Basic Oral Care
Intervention Description
Compliance with the Basic Oral Care only
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores
Time Frame
16 days for each patient
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years.
Patients with upper aero-digestive tract cancer receiving a first cervicofacial radiotherapy or chemoradiotherapy
Patients with a grade 2 mucositis (according to the NCI CTCAE version 5.0) appearing during treatment.
Patients available to perform the LLLT treatment: 5 visits at 3 days intervals
Patients must provide written informed consent prior to any study specific procedures.
Patients affiliated to a Social Health Insurance in France.
Exclusion Criteria:
Patients who have already received a cervicofacial radiotherapy
Patients who have already received an induction chemotherapy for their upper aero-digestive tract cancer
Patients under targeted therapy for their upper aero-digestive tract cancer
Patients under systemic corticotherapy
Patients with a non-grade 2 mucositis (according to the NCI CTCAE version 5.0)
Patients with ulceration or any other oral mucosa pathology than mucositis
Pregnant or breastfeeding women
Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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