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

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

Study Description
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

Study Design
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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 : August 29, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Proportion of grade 3-4 mucositis [ Time Frame: assessed at day 12 ± 2 days after initiation of chemotherapy ]

Eligibility Criteria
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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
  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)
Contacts and Locations

Contacts
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Contact: Léa Guerrini-Rousseau, MD 0142116741 ext +33 lea.guerrini-rousseau@gustaveroussy.fr
Contact: Rachid Abbas, MD 0142115398 ext +33 rachid.abbas@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94805
Contact: Léa Guerrini-Rousseau, MD    01422116741    lea.guerrini-rousseau@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE August 29, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		Proportion of grade 3-4 mucositis [ Time Frame: assessed at day 12 ± 2 days after initiation of chemotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults Treated for a Tumoral Disease
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Mucositis Oral
Intervention  ICMJE
  • 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).
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: preventive treatment with LLLT ("Laser" group)
    Intervention: Device: Low-Level Laser Therapy
  • Placebo Comparator: control group with a placebo intervention
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Léa Guerrini-Rousseau, MD 0142116741 ext +33 lea.guerrini-rousseau@gustaveroussy.fr
Contact: Rachid Abbas, MD 0142115398 ext +33 rachid.abbas@gustaveroussy.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983369
Other Study ID Numbers  ICMJE 2017-A03041-52
2017/2640 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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