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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)

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ClinicalTrials.gov Identifier: NCT03955224
Recruitment Status : Not yet recruiting
First Posted : May 20, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Basic Oral Care + active LLLT (experimental arm) 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)

Placebo Comparator: Basic oral Care + inactive LLLT (control arm) 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)

Basic Oral Care (control arm) Other: Basic Oral Care
Compliance with the Basic Oral Care only




Primary Outcome Measures :
  1. 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 Measures :
  1. Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores [ Time Frame: 16 days for each patient ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  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:

  1. Patients who have already received a cervicofacial radiotherapy
  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)

Information from the National Library of Medicine

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


Contacts
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Contact: Emmanuelle VIGARIOS 05 31 15 53 74 vigarios.emmanuelle@iuct-oncopole.fr

Locations
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France
Institut Universitaire du Cancer de Toulouse - Oncopole Not yet recruiting
Toulouse, France
Contact: Emmanuelle VIGARIOS    05 31 15 53 74    vigarios.emmanuelle@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03955224     History of Changes
Other Study ID Numbers: 19 VADS 04
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Upper Aerodigestive Tract Neoplasms
Low-Level Laser Therapy (LLLT)
Mucositis
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Neoplasms by Site