Upper Aerodigestive Tract NeoplasmsPhase 2ESMULLLATNCT03955224
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
A Phase 2 study testing Basic Oral Care + active LLLT, Basic oral Care + inactive LLLT and Basic Oral Care in people with Upper Aerodigestive Tract Neoplasms, run by Institut Claudius Regaud at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Aerodigestive Tract Neoplasms
- What is being tested?
- Basic Oral Care + active LLLT, Basic oral Care + inactive LLLT and Basic Oral Care
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2021to Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Upper Aerodigestive Tract Neoplasms
- Being tested
- Basic Oral Care + active LLLT, Basic oral Care + inactive LLLT, Basic Oral Care
- Keywords
- Upper Aerodigestive Tract Neoplasms, Low-Level Laser Therapy (LLLT), Mucositis
- Medical subject headings
- Head and Neck Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Oral Care + active LLLTDevice
- 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 LLLTOther
- 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 CareOther
Compliance with the Basic Oral Care only
| Study group | Role | What they receive |
|---|---|---|
| Basic Oral Care + active LLLT (experimental arm) | Active comparator | Not described Receives: Device: Basic Oral Care + active LLLT |
| Basic oral Care + inactive LLLT (control arm) | Placebo comparator | Not described Receives: Other: Basic oral Care + inactive LLLT |
| Basic Oral Care (control arm) | Other | Not described Receives: Other: Basic Oral Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who didn't need a dose increase or introduction of new analgesics for mouth pain during the study compared to baseline
Measured: 16 days for each patient
Secondary outcomes (3)
Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores
Measured: 16 days for each patient
Quality of Life assessed by the Quality of Life Questionnaire specific to Head and Neck cancer (H&N35)
Measured: 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
Measured: 16 days for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study startMar 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Withdrawn due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Aerodigestive Tract NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955224
- Sponsor's protocol ID
- 19 VADS 04
- Acronym
- ESMULLLAT
- Status last verified
- Mar 2021
- First submitted
- 16 May 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03955224
- Acronym / sponsor ID
- ESMULLLAT / 19 VADS 04
- Conditions
- Upper Aerodigestive Tract Neoplasms
- Keywords
- Upper Aerodigestive Tract Neoplasms, Low-Level Laser Therapy (LLLT), Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basic Oral Care + active LLLT (experimental arm) | Active comparator | Device: Basic Oral Care + active LLLT |
| Basic oral Care + inactive LLLT (control arm) | Placebo comparator | Other: Basic oral Care + inactive LLLT |
| Basic Oral Care (control arm) | Other | Other: Basic Oral Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Basic Oral Care + active LLLT (experimental 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) | Other | Basic oral Care + inactive LLLT (control arm) |
| Basic Oral CareCompliance with the Basic Oral Care only | Other | Basic Oral Care (control arm) |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Basic Oral Care + active LLLT, Basic oral Care + inactive LLLT and Basic Oral Care in people with Upper Aerodigestive Tract Neoplasms, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.