Using low-level laser therapy to prevent mouth sores in young cancer patients

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

This study is testing if low-level laser therapy can help prevent painful mouth sores in children and young adults receiving high-risk chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (estimated)
• Ages: 4 Years to 25 Years
• Sex: All
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Academic / other)
• Drugs / interventions: Bevacizumab, chemotherapy, Methotrexate, Cyclophosphamide, Fludarabine
• Locations: 5 sites (Villejuif, Val de Marne and 4 other locations)
• Trial ID: NCT03983369 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of low-level laser therapy (LLLT) in preventing severe oral mucositis in children and young adults undergoing high-risk chemotherapy regimens. Participants aged 4 to 25 years, who are free of mucositis at the start of treatment, will receive either LLLT or a placebo during their chemotherapy. The study aims to determine if LLLT can significantly reduce the incidence of grade 3-4 mucositis, which can cause severe pain and complications during cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 4 to 25 years receiving high-risk chemotherapy that is known to cause severe mucositis.

Not a fit: Patients who already have mucositis or other mouth lesions at the start of chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce the incidence of painful mouth sores in young cancer patients, improving their quality of life during treatment.

How similar studies have performed: Previous studies have shown promising results with low-level laser therapy in reducing mucositis in various patient populations, suggesting potential for success in this context.

Eligibility criteria

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 β-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)

Where this trial is running

Villejuif, Val de Marne and 4 other locations

• Gustave Roussy — Villejuif, Val de Marne, France (Recruiting)
• Centre Oscar Lambret — Lille, France (Recruiting)
• Hôpital Robert Debré — Paris, France (Recruiting)
• Institut Curie — Paris, France (Recruiting)
• CHU de Rennes — Rennes, France (Recruiting)

Study contacts

• Study coordinator: Léa Guerrini-Rousseau, MD

Conditions Mucositis Oral