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

NCT04756622 | Unknown Phase 3

• 1 other identifier: 1078-20
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mucositis; Transplant-Related Disorder

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with grade 3-4 OM

  Proportion of patients with grade 3-4 OM

  day 14

Secondary Outcomes (3)

• Proportion of patients with grade 1-4 OM

  14 days

• Time from transplantation to first hospital discharge

  30 days

• Non-relapse mortality

  day 50

Study Arms (2)

N acetyl cysteine

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention

Interventions

N acetyl cysteine DRUG

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.

N acetyl cysteine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known sensitivity to NAC

Sponsors & Collaborators

• moshe yeshurun: lead

MeSH Terms

Conditions

Mucositis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Moshe Yeshurun, MD

CONTACT

0526015543; moshe.yeshurun@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Bone Marrow UNit

Model Details: Phase III, randomized, open label and multi-center study.

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 16, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share