StomatitisPhase 3LAMPONCT02762019
Laser for Oral Mucositis in Pediatric Onco-hematology
A Phase 3 study testing Laser therapy in people with Stomatitis, run by IRCCS Burlo Garofolo at 8 sites in Italy.
Trial summary
Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side effects among which oral mucositis (OM) is one of the most debilitating. Modifications of CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor general conditions and debilitation. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Stomatitis
- What is being tested?
- Laser therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 8 sitesItaly
- Study dates
- Sep 2013to Oct 2015
- Phase
- Phase 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 3-18 years
- Oral mucositis of grade 3 or 4 at enrollment (CTC - WHO scale)
- Antiblastic chemotherapy in the in the previous three weeks
- Willingness to undergo treatment for 4 consecutive days and to return for evaluation 7 and 11 days after enrollment.
Who cannot join
- Previous treatment with laser therapy for stomatitis
- Presence of dysplastic oral lesions
- Reduction of mouth opening (<1 cm)
- Localized head and/or neck radiation treatment in the previous 4 weeks
- Use of keratinocyte growth factor (KGF)
- Previous enrollment in the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Policlinico Sant'Orsola Malpighi
Bologna
Spedali civili Ospedale dei Bambini
Brescia
Ospedale Pediatrico Microcitemico "Antonio Cao"
Cagliari
Azienda Ospedaliera di Padova
Padova
Azienda Ospedaliero universitaria di Parma
Parma
Fondazione IRCCS, Policlinico San Matteo
Pavia
A.O.U. Città della Salute e della Scienza di Torino
Torino
IRCCS Burlo Garofolo
Trieste
About this study
Official title: LAMPO: Multicenter Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Laser Therapy for Treatment of Oral Mucositis Induced by Chemotherapy in Children
Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side effects among which oral mucositis (OM) is one of the most debilitating. Modifications of CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor general conditions and debilitation. Moreover, the use of narcotic analgesics and total parenteral nutrition may be required, triggering not only a physical deficit but also an economic burden. Despite the frequency and impact of OM among children with cancer, there is no consensus on standard therapy for this condition. Previous studies demonstrated that high power laser therapy can help the maintenance of nutritional status in patients with OM and can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in reducing symptoms and in preventing the onset of OM in adult cancer patients but only one randomized controlled trial, with a limited number of children enrolled, supports its use in children for treatment of OM induced by chemotherapy.
This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years.
The study involves 8 italian hospitals.
- Conditions
- Stomatitis
- Being tested
- Laser therapy, Sham therapy
- Keywords
- Stomatitis, Laser, Children, Chemotherapy, Treatment
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyDevice
Treatment with K-Laser Cube3 during 4 consecutive days, with the following protocol: 660-970 nm wavelength, 3,2W mean power (6.4W pulsating at 50%), 3'51'' duration, 1-20000 Hz frequency, and 1 cm2 spot size. Laser application was performed all over the oral cavity.
Sham therapyDevice
Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy | Experimental | Children are allocated to receive Laser therapy Receives: Device: Laser therapy |
| Sham therapy | Sham comparator | Children are allocated to receive Sham therapy Receives: Device: Sham therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the grade of oral mucositis
Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the World Health Organization (WHO) evaluation scale
Measured: 7 days after enrollment
Secondary outcomes (10)
Reduction of the grade of oral mucositis
Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the WHO evaluation scale
Measured: 3 days after enrollment
Reduction of the grade of oral mucositis
Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the WHO evaluation scale
Measured: 11 days after enrollment
Reduction of pain, age 4-7 years
Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)
Measured: 3 days after enrollment
Reduction of pain, age 8-18 years
Reduction of self-reported pain recorded with a numeric rating scale
Measured: 3 days after enrollment
Reduction of pain, age 4-7 years
Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)
Measured: 7 days after enrollment
Reduction of pain, age 8-18 years
Reduction of self-reported pain recorded with a numeric rating scale
Measured: 7 days after enrollment
Reduction of pain, age 4-7 years
Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)
Measured: 11 days after enrollment
Reduction of pain, age 8-18 years
Reduction of self-reported pain recorded with a numeric rating scale
Measured: 11 days after enrollment
Reduction of need for analgesics
Measured: at day 7
Adverse events
Measured: at day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startSep 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Giulio Andrea Zanazzo, MD, Study chair, IRCCS Burlo Garofolo, TriesteMatteo Biasotto, DDS, Study chair, Azienda Ospedaliero Universitaria "Ospedali Riuniti", Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762019
- Sponsor's protocol ID
- RC 33/12
- Acronym
- LAMPO
- Status last verified
- May 2016
- First submitted
- 28 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAMPO: Multicenter Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Laser Therapy for Treatment of Oral Mucositis Induced by Chemotherapy in Children
- ClinicalTrials.gov ID
- NCT02762019
- Acronym / sponsor ID
- LAMPO / RC 33/12
- Conditions
- Stomatitis
- Keywords
- Stomatitis, Laser, Children, Chemotherapy, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 May 2016 (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.
Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side effects among which oral mucositis (OM) is one of the most debilitating. Modifications of CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor general conditions and debilitation. Moreover, the use of narcotic analgesics and total parenteral nutrition may be required, triggering not only a physical deficit but also an economic burden. Despite the frequency and impact of OM among children with cancer, there is no consensus on standard therapy for this condition. Previous studies demonstrated that high power laser therapy can help the maintenance of nutritional status in patients with OM and can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in reducing symptoms and in preventing the onset of OM in adult cancer patients but only one randomized controlled trial, with a limited number of children enrolled, supports its use in children for treatment of OM induced by chemotherapy.
This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years.
The study involves 8 italian hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser therapy | Experimental | Device: Laser therapyChildren are allocated to receive Laser therapy |
| Sham therapy | Sham comparator | Device: Sham therapyChildren are allocated to receive Sham therapy |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged 3-18 years
- Oral mucositis of grade 3 or 4 at enrollment (CTC - WHO scale)
- Antiblastic chemotherapy in the in the previous three weeks
- Willingness to undergo treatment for 4 consecutive days and to return for evaluation 7 and 11 days after enrollment.
Key exclusion criteria (6 listed)
- Previous treatment with laser therapy for stomatitis
- Presence of dysplastic oral lesions
- Reduction of mouth opening (<1 cm)
- Localized head and/or neck radiation treatment in the previous 4 weeks
- Use of keratinocyte growth factor (KGF)
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 |
|---|---|---|
| Laser therapyTreatment with K-Laser Cube3 during 4 consecutive days, with the following protocol: 660-970 nm wavelength, 3,2W mean power (6.4W pulsating at 50%), 3'51'' duration, 1-20000 Hz frequency, and 1 cm2 spot size. Laser application was performed all over the oral cavity. | Device | Laser therapy |
| Sham therapyOnly the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity. | Device | Sham therapy |
Primary outcome
Reduction of the grade of oral mucositis
Time frame: 7 days after enrollment
Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the World Health Organization (WHO) evaluation scale
10 secondary outcomes
Reduction of the grade of oral mucositis
Time frame: 3 days after enrollment
Reduction of the grade of oral mucositis
Time frame: 11 days after enrollment
Reduction of pain, age 4-7 years
Time frame: 3 days after enrollment
Reduction of pain, age 8-18 years
Time frame: 3 days after enrollment
Reduction of pain, age 4-7 years
Time frame: 7 days after enrollment
Reduction of pain, age 8-18 years
Time frame: 7 days after enrollment
Reduction of pain, age 4-7 years
Time frame: 11 days after enrollment
Reduction of pain, age 8-18 years
Time frame: 11 days after enrollment
Reduction of need for analgesics
Time frame: at day 7
Adverse events
Time frame: at day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Stomatitis
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Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
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Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
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
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 4
An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Stomatitis
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.
Giulio Andrea Zanazzo, MD study chair
IRCCS Burlo Garofolo, Trieste
Matteo Biasotto, DDS study chair
Azienda Ospedaliero Universitaria "Ospedali Riuniti", Trieste
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laser therapy in people with Stomatitis, run by IRCCS Burlo Garofolo at 8 sites in Italy.
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 4 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: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of the grade of oral mucositis (time frame: 7 days after enrollment). 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 4 May 2016.