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

• Sponsor: moshe yeshurun (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04756622
• Collaborator: (none)
• Enrollment: 116
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mucositis; Transplant-Related Disorder	Drug: N acetyl cysteine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase III, randomized, open label and multi-center study.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.
• Anticipated Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Proportion of patients with grade 3-4 OM [day 14]

   Proportion of patients with grade 3-4 OM

Secondary Outcome Measures

1. Proportion of patients with grade 1-4 OM [14 days]

   Proportion of patients with grade 1-4 OM

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

   Time from transplantation to first hospital discharge

3. Non-relapse mortality [day 50]

   Non-relapse mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• moshe yeshurun

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: moshe yeshurun, Head Bone Marrow UNit, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT04756622
• Other Study ID Numbers: 1078-20
• First Posted: Feb 16, 2021
• Last Update Posted: Feb 16, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mucositis; Stomatitis; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Feb 16, 2021