NCT03983369 Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults
| NCT ID | NCT03983369 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | Mucositis Oral |
| Study Type | INTERVENTIONAL |
| Enrollment | 315 participants |
| Start Date | 2018-08-29 |
| Primary Completion | 2026-08-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 315 participants in total. It began in 2018-08-29 with a primary completion date of 2026-08-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03983369 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 25 Years, studying Mucositis Oral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03983369 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 315 participants.
Is NCT03983369 currently recruiting?
Yes, NCT03983369 is actively recruiting participants. Contact the research team at lea.guerrini-rousseau@gustaveroussy.fr for enrollment information.
Where is the NCT03983369 trial being conducted?
This trial is being conducted at Villejuif, France, Lille, France, Paris, France, Paris, France and 1 additional location.
Who is sponsoring the NCT03983369 clinical trial?
NCT03983369 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 315 participants.