A Phase 3 interventional study of Low-Level Laser Therapy and Placebo in Mucositis Oral, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Recruiting at 5 sites in France. Open to participants aged 4 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 3, Interventional, and Treatment
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).
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 315 is above the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 245 studies on the registry; 66 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients undergoing chemotherapy course with high risk of severe mucositis :
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Low-Level Laser Therapy
Other: Placebo
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).
Placebo
Proportion of grade 3-4 mucositis
Time frame: assessed at day 12 ± 2 days after initiation of chemotherapy
Plan to share: Undecided
No publications or documents are linked to this record.
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Gustave Roussy, Cancer Campus, Grand Paris →