Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults

Mucositis Oral Clinical Trial

— MUCILA  

Official title:

Multicenter Double Blind Randomized Placebo-controlled Trial Assessing the Efficacy of Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983369
• Other study ID #: 2017-A03041-52
• Secondary ID: 2017/2640
• Status: Recruiting
• Phase: Phase 3
• Start date: August 29, 2018
• Est. completion date: September 2023

Study information

• Verified date: May 2023
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Léa Guerrini-Rousseau, MD
• Phone: +33 (0)1 42 11 67 41
• Email: lea.guerrini-rousseau[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Age > 4 and = 25 years

2. No mucositis or other mouth lesions at the beginning of chemotherapy that could prevent the laser session and chemotherapy

3. Cooperative patient, able to wear black glasses and to sit with his open mouth during laser session

4. Patients treated in one of the SFCE centers that participate to the study

5. Patients undergoing chemotherapy course with high risk of severe mucositis :

1. high-dose chemotherapy with hematological stem cell transplantation (stratum A) including but not limited to 8 HDC conditioning regimens for solid tumors intensive treatment (Busilvex-Melphalan, VP16-Thiotepa, BAM, BEAM, Thiotepa 900mg/m^2, Carboplatine-Thiotepa (typical teratoid rhabdoid tumor or medulloblastoma), VP16-Carboplatine-Thiotepa, Endoxan-Busilvex and VP16 - Melphalan) and 5 myeloablative conditioning regimens (for example : TBI-VP16, Busilvex-Endoxan-Thiotepa, Busilvex-Endoxan+/-Melphalan and Thiotepa-Busulfan-Fludarabine),

2. Conventional chemotherapy courses (stratum B) but not limited to COPADM (B lymphoma), CAV/ICE (plexus choroid carcinoma or B lymphoma), Head start induction course (medulloblastoma), N6 course (neuroblastoma), VIDE or VCD (Ewing sarcoma), API/AP (osteosarcoma), Cyclophosphamide and Doxorubicine (nephroblastoma), PLADO/Carboplatine and Doxorubicine (hepatoblastoma), IVADo (rhabdomyosarcoma), induction and consolidation of the Myechild protocol (Cytarabine/Mithoxantrone Fludarabine Aractine +/- Darubicine) (acute myeloid leukemia) and 5FU-cisplatine (undifferentiated carcinoma of nasopharyngeal),

3. Others courses of chemotherapy (stratum A or B) which may cause mucositis can be considered (please refer to the non-inclusion criterion n° 5 to see the prohibited chemotherapy list). In this case, the coordinating investigator approval is required.

6. Women of childbearing potential must have a negative serum ß-HCG pregnancy test prior to the administration of the first laser treatment.

7. French speaking patients

8. 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.

9. 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:

1. Treatment by opioids on daily basis

2. Orthodontic appliance

3. Pregnant or breastfeeding young ladies or women

4. Patients with cognitive disorder who could not self-evaluate his pain or with a mucositis difficult to evaluate

5. None of this chemotherapy is allowed : Methotrexate, VA or VAD (nephroblastoma), Carboplatine - Etoposide (3 or 5 days), Temozolomide single agent or in combination with Topotecan/Irinotecan or Bevacizumab, Gemzar, Taxotere, Ifosfamide - Etoposide (Ewing sarcoma), OEPA, COPDAC, IgEV (Hodgkin lymphoma)

Related Conditions & MeSH terms

• Mucositis
• Mucositis Oral
• Stomatitis

Intervention

Device:
• Low-Level Laser Therapy
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).

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Hôpital Robert Debré	Paris
France	Institut Curie	Paris
France	CHU de Rennes	Rennes
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of grade 3-4 mucositis		assessed at day 12 ± 2 days after initiation of chemotherapy