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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04756622

Enrollment

116

Registered

2021-02-16

Start date

2021-04-01

Completion date

2023-03-31

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis, Transplant-Related Disorder

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.

Interventions

DRUGN 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with grade 3-4 OM	day 14	Proportion of patients with grade 3-4 OM

Secondary

Measure	Time frame	Description
Proportion of patients with grade 1-4 OM	14 days	Proportion of patients with grade 1-4 OM
Time from transplantation to first hospital discharge	30 days	Time from transplantation to first hospital discharge
Non-relapse mortality	day 50	Non-relapse mortality

Contacts

Primary ContactMoshe Yeshurun, MD

moshe.yeshurun@gmail.com0526015543

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026