Oral MucositisPhase 2/3NCT01007617
Low-energy Laser Therapy for Prevention of Oral Mucositis in Children
A Phase 2/3 study testing LLLT :low level laser therapy in people with Oral Mucositis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Oral mucositis represents a major complication of cytotoxic chemotherapy among cancer in children. Low-power laser therapy (LPLT) has been used to reduce the incidence of oral mucositis in patients who are receiving high-dose chemotherapy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- LLLT :low level laser therapy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Jul 2010
- Phase
- Phase 2/3
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 0 at 18 years
- patients receiving therapy with agents likely to cause severe mucositis (grade 3 or 4)
- Patients who had developed severe mucositis previously in any chemotherapy, and receiving the same.
- Healthy oral mucosa
- informed consent
Who cannot join
- - Infection active and proved, viral, bacterial or fungal oral cavity
- Malignant pathology in the oral cavity
- Preliminary local irradiation of the oral cavity
- Simultaneous treatment by an agent of prevention or treatment of mucositis in investigation
- Inclusion in a protocol with oral mucositis as one of the assessment criteria
- Absence of consent lit by parents or child
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Patrick LACARIN, 04.73.75.11.95, placarin@chu-clermontferrand.fr
About this study
Official title: Evaluation of Low-energy Laser Therapy for Prevention and Reduction of Severity of Oral Mucositis in Children "Mucositis Laser 1"
Oral mucositis represents a major complication of cytotoxic chemotherapy among cancer in children. Low-power laser therapy (LPLT) has been used to reduce the incidence of oral mucositis in patients who are receiving high-dose chemotherapy. The aim of this study is to compare two preventives energies delivered of LPLT to oral mucosa in decreasing the severity of mucositis in children.
Read the detailed description
Mucositis is one of the main complications of cytotoxic chemotherapy and total body irradiation in children cancers. Local and systemic treatments are not efficiency or limited by side effects, (particularly for opioid). Two randomized recent studies in adult have showed the efficiency of LPLT (wavelength 650nm at the intensity of 4J/cm²) in prevention of severe mucositis. In pediatrics patient, only one randomized study was performed to the same intensity of 4J/cm² but with a wavelength of 732nm, and did not show the evidence of profit. In theory, tissues absorption level of laser is similar at 650 and 900nm but lower around 700nm. Procedure was very well tolerated by children; the main limiting factor is the deadline directly proportional to intensity delivered.
The aim of our study is to compare two preventives energies (2J/cm² or 8 J/cm²) daily delivered of LPLT to oral mucosa in decreasing the severity of mucositis in children. Placebo study was not possible to our opinion and we preferred to compare two intensity of LPLT for three reasons : being given the sensation of heat generated by the treatment, a true placebo is difficult to obtain; considering the difficulties proceeding to large-sized clinical trials in this population, it seems to us necessary to end quickly in an optimal protocol; the main inconvenience of LPLT is the duration of the sessions, so in case of negative result, our study will generate data allowing not to realize useless too long sessions.
It's a prospective controlled study, randomized in double blind phase II, in one center. All the patients will receive LPLT (GaAlAs, wavelength 980nm) daily of the 1st in the 5th day of cytotoxic treatment. The patients will be randomized in 2 groups according to the delivered dose: 2 J/cm2/d or 8 J/cm2/d.
Main evaluation criteria: mucositis maximal intensity (WHO scale) Secondary evaluation criteria: mucositis duration, mucositis survival free, pain, opioid treatment, hospitalization, fever and infection, nutrition.
Expected clinical effects: improvement of the children's comfort; dissemination of the technique in the other oncology pediatric centers
- Conditions
- Oral Mucositis
- Being tested
- LLLT :low level laser therapy
- Keywords
- Children, Cancer, Mucositis, Laser, Prevention, Chemotherapy, Children with malignancies receiving chemotherapy and/or radiotherapy inducing severe mucositis
- Medical subject headings
- Stomatitis, Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLLT :low level laser therapyDevice
The patients will be randomized in 2 groups according to the delivered dose: 2 J/cm2/d or 8 J/cm2/d.
Main evaluation criteria: mucositis maximal intensity (WHO scale).
Secondary evaluation criteria: mucositis duration, mucositis survival free, pain, opioid treatment, hospitalization, fever and infection, nutrition.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucositis scale - World Health Organization (WHO)
Measured: after delivering a dose of 2 J/cm2/d
Secondary outcomes (8)
Mucositis period
Measured: after delivering a dose of 8 J/cm2/d
Mucositis free survival
Measured: after delivering a dose of 8 J/cm2/d
Pain intensity
Measured: after delivering a dose of 8 J/cm2/d
Morphinic administration
Measured: after delivering a dose of 8 J/cm2/d
Duration of hospitalisation
Measured: after delivering a dose of 8 J/cm2/d
Febrile neutropenia
Measured: after delivering a dose of 8 J/cm2/d
Duration of parenteral nutrition
Measured: after delivering a dose of 8 J/cm2/d
Psychological impact
Measured: after delivering a dose of 8 J/cm2/d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Faculté de chirurgie dentaire, Clermont-Ferrand, Centre de Pharmacologie Clinique, INSERM CIC 501, Laboratoire des Matériaux Inorganiques, ESA CNRS 6002 et ENSCCF, Université Blaise-Pascal, Aubière
- Investigators
- Etienne MERLIN, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007617
- Sponsor's protocol ID
- CHU-0060
- Status last verified
- Jan 2011
- First submitted
- 3 Nov 2009
- Last updated
- 19 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-energy Laser Therapy for Prevention and Reduction of Severity of Oral Mucositis in Children "Mucositis Laser 1"
- ClinicalTrials.gov ID
- NCT01007617
- Acronym / sponsor ID
- CHU-0060
- Conditions
- Oral Mucositis
- Keywords
- Children, Cancer, Mucositis, Laser, Prevention, Chemotherapy, Children with malignancies receiving chemotherapy and/or radiotherapy inducing severe mucositis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Faculté de chirurgie dentaire, Clermont-Ferrand, Centre de Pharmacologie Clinique, INSERM CIC 501, Laboratoire des Matériaux Inorganiques, ESA CNRS 6002 et ENSCCF, Université Blaise-Pascal, Aubière
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 4 Nov 2009 (estimated)
- 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.
Oral mucositis represents a major complication of cytotoxic chemotherapy among cancer in children. Low-power laser therapy (LPLT) has been used to reduce the incidence of oral mucositis in patients who are receiving high-dose chemotherapy. The aim of this study is to compare two preventives energies delivered of LPLT to oral mucosa in decreasing the severity of mucositis in children.
Detailed description
Mucositis is one of the main complications of cytotoxic chemotherapy and total body irradiation in children cancers. Local and systemic treatments are not efficiency or limited by side effects, (particularly for opioid). Two randomized recent studies in adult have showed the efficiency of LPLT (wavelength 650nm at the intensity of 4J/cm²) in prevention of severe mucositis. In pediatrics patient, only one randomized study was performed to the same intensity of 4J/cm² but with a wavelength of 732nm, and did not show the evidence of profit. In theory, tissues absorption level of laser is similar at 650 and 900nm but lower around 700nm. Procedure was very well tolerated by children; the main limiting factor is the deadline directly proportional to intensity delivered.
The aim of our study is to compare two preventives energies (2J/cm² or 8 J/cm²) daily delivered of LPLT to oral mucosa in decreasing the severity of mucositis in children. Placebo study was not possible to our opinion and we preferred to compare two intensity of LPLT for three reasons : being given the sensation of heat generated by the treatment, a true placebo is difficult to obtain; considering the difficulties proceeding to large-sized clinical trials in this population, it seems to us necessary to end quickly in an optimal protocol; the main inconvenience of LPLT is the duration of the sessions, so in case of negative result, our study will generate data allowing not to realize useless too long sessions.
It's a prospective controlled study, randomized in double blind phase II, in one center. All the patients will receive LPLT (GaAlAs, wavelength 980nm) daily of the 1st in the 5th day of cytotoxic treatment. The patients will be randomized in 2 groups according to the delivered dose: 2 J/cm2/d or 8 J/cm2/d.
Main evaluation criteria: mucositis maximal intensity (WHO scale) Secondary evaluation criteria: mucositis duration, mucositis survival free, pain, opioid treatment, hospitalization, fever and infection, nutrition.
Expected clinical effects: improvement of the children's comfort; dissemination of the technique in the other oncology pediatric centers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 0 at 18 years
- patients receiving therapy with agents likely to cause severe mucositis (grade 3 or 4)
- Patients who had developed severe mucositis previously in any chemotherapy, and receiving the same.
- Healthy oral mucosa
- informed consent
Key exclusion criteria (6 listed)
- - Infection active and proved, viral, bacterial or fungal oral cavity
- Malignant pathology in the oral cavity
- Preliminary local irradiation of the oral cavity
- Simultaneous treatment by an agent of prevention or treatment of mucositis in investigation
- Inclusion in a protocol with oral mucositis as one of the assessment criteria
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 |
|---|---|---|
| LLLT :low level laser therapyThe patients will be randomized in 2 groups according to the delivered dose: 2 J/cm2/d or 8 J/cm2/d. Main evaluation criteria: mucositis maximal intensity (WHO scale). Secondary evaluation criteria: mucositis duration, mucositis survival free, pain, opioid treatment, hospitalization, fever and infection, nutrition. | Device | – |
Primary outcome
Mucositis scale - World Health Organization (WHO)
Time frame: after delivering a dose of 2 J/cm2/d
8 secondary outcomes
Mucositis period
Time frame: after delivering a dose of 8 J/cm2/d
Mucositis free survival
Time frame: after delivering a dose of 8 J/cm2/d
Pain intensity
Time frame: after delivering a dose of 8 J/cm2/d
Morphinic administration
Time frame: after delivering a dose of 8 J/cm2/d
Duration of hospitalisation
Time frame: after delivering a dose of 8 J/cm2/d
Febrile neutropenia
Time frame: after delivering a dose of 8 J/cm2/d
Duration of parenteral nutrition
Time frame: after delivering a dose of 8 J/cm2/d
Psychological impact
Time frame: after delivering a dose of 8 J/cm2/d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
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Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
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High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
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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.
Etienne MERLIN, MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LLLT :low level laser therapy in people with Oral Mucositis, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Jan 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04.73.75.11.95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucositis scale - World Health Organization (WHO) (time frame: after delivering a dose of 2 J/cm2/d). 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 19 Jan 2011.