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

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ClinicalTrials.gov Identifier: NCT04756622
Recruitment Status : Not yet recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
moshe yeshurun, Rabin Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mucositis Transplant-Related Disorder Drug: N acetyl cysteine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III, randomized, open label and multi-center study.
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: N acetyl cysteine
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.
 Drug: N acetyl cysteine
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.
No Intervention: Control
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with grade 3-4 OM [ Time Frame: day 14 ]
    Proportion of patients with grade 3-4 OM


Secondary Outcome Measures :
  1. Proportion of patients with grade 1-4 OM [ Time Frame: 14 days ]
    Proportion of patients with grade 1-4 OM

  2. Time from transplantation to first hospital discharge [ Time Frame: 30 days ]
    Time from transplantation to first hospital discharge

  3. Non-relapse mortality [ Time Frame: day 50 ]
    Non-relapse mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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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): NCT04756622


Contacts
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Contact: Moshe Yeshurun, MD 0526015543 moshe.yeshurun@gmail.com

Sponsors and Collaborators
moshe yeshurun
More Information
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Responsible Party: moshe yeshurun, Head Bone Marrow UNit, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04756622    
Other Study ID Numbers: 1078-20
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
 Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes