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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mucositis Transplant-Related Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

N acetyl cysteine

Intervention Type 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.

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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