Laser light may stop chemo mouth sores in children
NCT ID NCT03983369
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether low-level laser therapy can prevent severe mouth sores (mucositis) caused by chemotherapy in children and young adults aged 4 to 25. The laser is a painless, non-heating light applied to the mouth before chemotherapy. The trial is double-blind and placebo-controlled, meaning some participants get a sham laser. If successful, it could offer a safe, drug-free way to reduce a common and painful side effect of cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-level laser therapy (LLLT) device
- What this could lead to
- If it works, this could give doctors a simple, non-drug way to prevent painful mouth sores in young cancer patients undergoing chemotherapy.
- What could go wrong
- This is a Phase 3 trial, but the effect may be modest or no better than placebo. The laser device requires cooperation from children, which may limit its use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 315 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2018
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Rennes
RECRUITINGRennes, 35203, France
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Centre Oscar Lambret
RECRUITINGLille, 59020, France
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Gustave Roussy
RECRUITINGVillejuif, Val de Marne, 94805, France
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Hôpital Robert Debré
RECRUITINGParis, 75019, France
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Institut Curie
RECRUITINGParis, 75248, France
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