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

Upper Aerodigestive Tract Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03955224
• Other study ID #: 19 VADS 04
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2021
• Est. completion date: October 2022

Study information

• Verified date: March 2021
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Stomatitis
• Upper Aerodigestive Tract Neoplasms

Intervention

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)

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
Compliance with the Basic Oral Care only

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who didn't need a dose increase or introduction of new analgesics for mouth pain during the study compared to baseline		16 days for each patient
Secondary	Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores		16 days for each patient
Secondary	Quality of Life assessed by the Quality of Life Questionnaire specific to Head and Neck cancer (H&N35)		16 days for each patient
Secondary	Frequency of adverse events related to the LLLT using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 5.0		16 days for each patient