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
NCT ID: NCT03955224
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-03-31
2022-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Basic Oral Care + active LLLT (experimental arm)
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)
Basic oral Care + inactive LLLT (control arm)
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)
Basic Oral Care (control arm)
Basic Oral Care
Compliance with the Basic Oral Care only
Interventions
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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)
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)
Basic Oral Care
Compliance with the Basic Oral Care only
Eligibility Criteria
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Inclusion Criteria
2. Patients with upper aero-digestive tract cancer receiving a first cervicofacial radiotherapy or chemoradiotherapy
3. Patients with a grade 2 mucositis (according to the NCI CTCAE version 5.0) appearing during treatment.
4. Patients available to perform the LLLT treatment: 5 visits at 3 days intervals
5. Patients must provide written informed consent prior to any study specific procedures.
6. Patients affiliated to a Social Health Insurance in France.
Exclusion Criteria
2. Patients who have already received an induction chemotherapy for their upper aero-digestive tract cancer
3. Patients under targeted therapy for their upper aero-digestive tract cancer
4. Patients under systemic corticotherapy
5. Patients with a non-grade 2 mucositis (according to the NCI CTCAE version 5.0)
6. Patients with ulceration or any other oral mucosa pathology than mucositis
7. Pregnant or breastfeeding women
8. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
9. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
18 Years
ALL
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Countries
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Other Identifiers
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19 VADS 04
Identifier Type: -
Identifier Source: org_study_id
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