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Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults Treated for a Tumoral Disease (MUCILA)

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ClinicalTrials.gov Identifier: NCT03983369
Recruitment Status : Active, not recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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 ofmucositis: conventional chemotherapy or High Dose Chemotherapy (HDC) conditioning regimens with Hematological Stem Cell Transplantation (HSCT).

Condition or disease Intervention/treatment Phase
Mucositis Oral Device: Low-Level Laser Therapy Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a superiority trial, multicenter, prospective, randomized in two parallel groups (containing a placebo control group) and a double-blind assessment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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).
Primary Purpose: Treatment
Official Title: 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 Treated for a Tumoral Disease
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: preventive treatment with LLLT ("Laser" group) Device: Low-Level Laser Therapy
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 Comparator: control group with a placebo intervention Other: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of grade 3-4 mucositis [ Time Frame: assessed at day 12 ± 2 days after initiation of chemotherapy ]


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Ages Eligible for Study:   4 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 a chemotherapy with high risk of severe mucositis

    1. HDC and HSCT (stratum A) including 8 HDC conditioning regimens for solid tumors intensive treatment (Busilvex- Melphalan, VP16-Thiotepa, BAM, BEAM, Thiotepa 900mg/m², Carboplatine-Thiotepa, Endoxan-Busilvex and VP16 - Melphalan) and 4 allograft conditioning regimens (TBI -VP16, Busilvex-Endoxan-Thiotepa and Busilvex-Endoxan+/-Melphalan)
    2. Conventional chemotherapy courses (stratum B): COPADM (Burkitt), CAV (neuroblastoma), VIDE (Ewing sarcoma) and 5FU-cisplatine (undifferentiated carcinoma of nasopharyngeal type)
  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 protocolspecific 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983369


Locations
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France
Gustave Roussy
Villejuif, Val De Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT03983369     History of Changes
Other Study ID Numbers: 2017-A03041-52
2017/2640 ( Other Identifier: CSET number )
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases