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

moshe yeshurun

Status and phase: Unknown; Phase 3

Conditions: Transplant-Related Disorder; Mucositis

Treatments: Drug: N acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT04756622

1078-20

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

N acetyl cysteine

Experimental group

Description:

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.

Treatment:

Drug: N acetyl cysteine

Control

No Intervention group

Description:

No intervention