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| ID | Type | Description | Link |
|---|---|---|---|
| 2017/2640 | Other Identifier | CSET number |
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To assess the efficacy of preventive Low-Level Laser Therapy (LLLT) for reducing the incidence of WHO's grade 3-4 oral mucositis in children and young adults receiving chemotherapy regimens associated with a high rate of mucositis: conventional chemotherapy or High Dose Chemotherapy (HDC) conditioning regimens with Hematological Stem Cell Transplantation (HSCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preventive treatment with LLLT ("Laser" group) | Experimental |
| |
| control group with a placebo intervention | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Level Laser Therapy | Device | The LLL used is the K-Laser Cube 3. The LLL is an athermal laser beam of low power, equipped with a placebo function (dummy imitating beam laser light, emitted by the same device but without physiological effect). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of grade 3-4 mucositis | assessed at day 12 ± 2 days after initiation of chemotherapy |
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Inclusion Criteria:
Age > 4 and ≤ 25 years
No mucositis or other mouth lesions at the beginning of chemotherapy that could prevent the laser session and chemotherapy
Cooperative patient, able to wear black glasses and to sit with his open mouth during laser session
Patients treated in one of the SFCE centers that participate to the study
Patients undergoing chemotherapy course with high risk of severe mucositis :
Women of childbearing potential must have a negative serum β-HCG pregnancy test prior to the administration of the first laser treatment.
French speaking patients
Patient and/or parents/legal representatives should understand, sign, and date the written informed consent form prior to any protocol specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
Patients must be affiliated to a social security regimen or beneficiary of the same
NB : all patients who respect all the eligibility criteria are recruitable even if the patient haven't a cancer (Patients undergoing a chemotherapy with high risk of severe mucositis for another clinical reason than cancer).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Léa Guerrini-Rousseau, MD | Contact | +33 (0)1 42 11 67 41 | lea.guerrini-rousseau@gustaveroussy.fr | |
| Jérémy MIONE, MS | Contact | +33 (0)1 42 11 42 11 | 38 61 | jeremy.mione@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Recruiting | Villejuif | Val de Marne | 94805 | France |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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This is a superiority trial, multicenter, prospective, randomized in two parallel groups (containing a placebo control group) and a double-blind assessment
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Multicenter randomized double blind placebo-controlled trial stratified according to the type of chemotherapy (Stratum A and B) and by center. Patients will be randomized in two parallel groups: preventive treatment with LLLT ("Laser" group) or a control group with a placebo intervention ("Placebo" group).
| Placebo | Other | Placebo |
|
| Centre Oscar Lambret | Recruiting | Lille | 59020 | France |
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| Hôpital Robert Debré | Recruiting | Paris | 75019 | France |
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| Institut Curie | Recruiting | Paris | 75248 | France |
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| CHU de Rennes | Recruiting | Rennes | 35203 | France |
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