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Safety and Efficacy of N-Acetylcysteine Mouthwash in Prevention of Mucositis in HSCT Patients
Sponsor: Tehran University of Medical Sciences
Summary
Oral mucositis (OM) is one of the most frequent complications in patients who undergo HSCT. It not only causes severe discomfort but also affects treatment adherence and increases hospital stays. In this study, we aim to assess whether using N-acetylcysteine mouthwash can safely and effectively prevent OM. The trial is randomized and conducted in the hematology wards of TUMS-affiliated RIOHCT, including both autologous and allogeneic HSCT patients.
Official title: Evaluating the Safety and Efficacy of N-acetylcysteine Mouthwash on the Prevention of Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation: a Double-blind Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 66 Years
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2024-08-18
Completion Date
2026-02
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
N-Acetylcysteine 600mg/tab
Each dose consists of one 600 mg effervescent tablet of N-acetylcysteine (NAC) dissolved in 20 mL of sodium carbonate solution. Participants receive this mouthwash four times daily, totaling 2400 mg of NAC per day. The solution is used as an oral rinse (swish and spit) and is not intended to be swallowed. Administration begins with the conditioning regimen and continues until day 14 after HSCT.
Placebo
Each dose consists of one placebo effervescent tablet, identical in appearance and packaging to the N-acetylcysteine tablets, dissolved in 20 mL of sodium carbonate solution. Participants use this placebo mouthwash four times daily as an oral rinse (swish and spit), starting from the conditioning regimen and continuing until day 14 post-transplantation. The placebo contains no active pharmaceutical ingredients.
Locations (1)
Research Institute of Oncology, Hematology, and Cell Therapy, Shariati Hospital
Tehran, Iran