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

NCT03983369 | Recruiting Phase 3

• 2 other identifiers: 2017-A03041-522017/2640
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Mucositis Oral

Outcome Measures

Primary Outcomes (1)

• Proportion of grade 3-4 mucositis

  assessed at day 12 ± 2 days after initiation of chemotherapy

Study Arms (2)

preventive treatment with LLLT ("Laser" group)

EXPERIMENTAL

Device: Low-Level Laser Therapy

control group with a placebo intervention

PLACEBO COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

Placebo

control group with a placebo intervention

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).

preventive treatment with LLLT ("Laser" group)

Eligibility Criteria

• Age: 4 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 :
• 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),
• 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),
• 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).

You may not qualify if:

• Treatment by opioids on daily basis
• Orthodontic appliance
• Pregnant or breastfeeding young ladies or women
• Patients with cognitive disorder who could not self-evaluate his pain or with a mucositis difficult to evaluate
• 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)

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (5)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

RECRUITING

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

Hôpital Robert Debré

Paris, 75019, France

RECRUITING

Institut Curie

Paris, 75248, France

RECRUITING

CHU de Rennes

Rennes, 35203, France

RECRUITING

MeSH Terms

Conditions

Stomatitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

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; jeremy.mione@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a superiority trial, multicenter, prospective, randomized in two parallel groups (containing a placebo control group) and a double-blind assessment

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: August 29, 2018
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (5)