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Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation. (AutoSelenium)

Primary Purpose

Mucositis Oral, Stem Cell Transplant Complications

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Selenium
Placebos
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mucositis Oral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma.
  • Signed informed consent.

Exclusion Criteria:

  • Autologous stem cell transplantation for another medical condition than lymphoma or myéloma.
  • Intolerance to selenium.
  • High selenium levels before study.
  • Pregnancy or patients breast-feeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Selenium

    Arm Description

    Usual care

    Usual care + selenium 300 µg/day (IV infusion)

    Outcomes

    Primary Outcome Measures

    Incidence of severe oral mucositis (grade 3-4)

    Secondary Outcome Measures

    Incidence of any grade oral mucositis
    Number of days with severe oral mucositis
    Incidence of infectious complications
    Number of days with artifical nutrition
    Number of days with opioids
    Duration of hospitalization

    Full Information

    First Posted
    September 2, 2019
    Last Updated
    September 5, 2019
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04080622
    Brief Title
    Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
    Acronym
    AutoSelenium
    Official Title
    A Randomized Trial to Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Chemotherapy-induced mucositis is an important complication after autologous stem cell transplantation. It is mainly responsible for pain and dysphagia requiring opioids and artificial nutrition. It can also induce infectious complications. A few medication has demonstrated efficacy in this setting. It has been suggested that selenium can reduce the intensity of mucositis due to its antioxydant activity. The investigators therefore perform a randomized study to confirm this preliminary data.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mucositis Oral, Stem Cell Transplant Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Usual care
    Arm Title
    Selenium
    Arm Type
    Active Comparator
    Arm Description
    Usual care + selenium 300 µg/day (IV infusion)
    Intervention Type
    Drug
    Intervention Name(s)
    Selenium
    Intervention Description
    Selenium 300 µg/day (IV infusion)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    NaCl 0,9% (IV infusion)
    Primary Outcome Measure Information:
    Title
    Incidence of severe oral mucositis (grade 3-4)
    Time Frame
    31 months
    Secondary Outcome Measure Information:
    Title
    Incidence of any grade oral mucositis
    Time Frame
    31 months
    Title
    Number of days with severe oral mucositis
    Time Frame
    31 months
    Title
    Incidence of infectious complications
    Time Frame
    31 months
    Title
    Number of days with artifical nutrition
    Time Frame
    31 months
    Title
    Number of days with opioids
    Time Frame
    31 months
    Title
    Duration of hospitalization
    Time Frame
    31 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma. Signed informed consent. Exclusion Criteria: Autologous stem cell transplantation for another medical condition than lymphoma or myéloma. Intolerance to selenium. High selenium levels before study. Pregnancy or patients breast-feeding.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Corentin Orvain, MD
    Phone
    33241354475
    Email
    corentin.orvain@chu-angers.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.

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