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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04756622
Other study ID # 1078-20
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2021
Est. completion date March 31, 2023

Study information

Verified date February 2021
Source Rabin Medical Center
Contact Moshe Yeshurun, MD
Phone 0526015543
Email moshe.yeshurun@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 116
Est. completion date March 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
moshe yeshurun

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with grade 3-4 OM Proportion of patients with grade 3-4 OM day 14
Secondary Proportion of patients with grade 1-4 OM Proportion of patients with grade 1-4 OM 14 days
Secondary Time from transplantation to first hospital discharge Time from transplantation to first hospital discharge 30 days
Secondary Non-relapse mortality Non-relapse mortality day 50
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