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N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.

Primary Purpose

Mucositis, Transplant-Related Disorder

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
N acetyl cysteine
Sponsored by
moshe yeshurun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mucositis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with multiple myeloma and lymphoma in partial response and complete remission.
  • Undergoing high-dose chemotherapy with autologous transplantation.

Exclusion Criteria:

• Known sensitivity to NAC

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    N acetyl cysteine

    Control

    Arm Description

    NAC dissolved in water at a dose of 600 mg three times per day from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.

    No intervention

    Outcomes

    Primary Outcome Measures

    Proportion of patients with grade 3-4 OM
    Proportion of patients with grade 3-4 OM

    Secondary Outcome Measures

    Proportion of patients with grade 1-4 OM
    Proportion of patients with grade 1-4 OM
    Time from transplantation to first hospital discharge
    Time from transplantation to first hospital discharge
    Non-relapse mortality
    Non-relapse mortality

    Full Information

    First Posted
    February 10, 2021
    Last Updated
    February 11, 2021
    Sponsor
    moshe yeshurun
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04756622
    Brief Title
    N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.
    Official Title
    Efficacy and Safety of N-acetyl Cysteine for the Prevention of Oral Mucositis After High-dose Chemotherapy and Autologous Hematopoietic Cell Transplantation: a Phase III, Randomized, Open Label, Multi-center Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    moshe yeshurun

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Oral mucositis (OM) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (HCT). N-acetyl cysteine (NAC) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of NAC in the prevention of OM after high-dose chemotherapy and autologous HCT in a phase III, randomized, open label and multi-center study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mucositis, Transplant-Related Disorder

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Phase III, randomized, open label and multi-center study.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    116 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    N acetyl cysteine
    Arm Type
    Experimental
    Arm Description
    NAC dissolved in water at a dose of 600 mg three times per day from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Drug
    Intervention Name(s)
    N acetyl cysteine
    Intervention Description
    N acetyl cysteine dissolved in water at a dose of 600 mg three times daily from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.
    Primary Outcome Measure Information:
    Title
    Proportion of patients with grade 3-4 OM
    Description
    Proportion of patients with grade 3-4 OM
    Time Frame
    day 14
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with grade 1-4 OM
    Description
    Proportion of patients with grade 1-4 OM
    Time Frame
    14 days
    Title
    Time from transplantation to first hospital discharge
    Description
    Time from transplantation to first hospital discharge
    Time Frame
    30 days
    Title
    Non-relapse mortality
    Description
    Non-relapse mortality
    Time Frame
    day 50

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with multiple myeloma and lymphoma in partial response and complete remission. Undergoing high-dose chemotherapy with autologous transplantation. Exclusion Criteria: • Known sensitivity to NAC
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moshe Yeshurun, MD
    Phone
    0526015543
    Email
    moshe.yeshurun@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.

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