Back to resultsN-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
About this trial
This is an interventional prevention trial for Mucositis
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
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
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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