Active — Not RecruitingPhase 3

Safety and Efficacy of N-Acetylcysteine Mouthwash in Prevention of Mucositis in HSCT Patients

Iran106 participantsStarted 2024-08-18

Plain-language 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.

Who can participate

Age range18 Years – 66 Years

SexALL

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Inclusion Criteria: * Patients undergoing hematopoietic stem cell transplantation (HSCT), including both allogeneic and autologous transplants * Age ≥18 years * Ability to provide informed consent Exclusion Criteria: * Known hypersensitivity to N-acetylcysteine or any components of the effervescent tablets * Inability to adhere to the proper use of mouthwash * Systemic use of N-acetylcysteine during the study period * Pregnancy or lactation

What they're measuring

Incidence of oral mucositis

Timeframe: From day 1 of conditioning to day +14 post-transplantation.

Incidence of N-acetylcysteine-related Adverse Events

Timeframe: Clinical examination is performed daily from the beginning of the conditioning regimen until day +14 post-transplantation.

Incidence of Severe Oral Mucositis

Timeframe: From day 1 of conditioning to day +14 post-transplantation

Trial details

NCT IDNCT07325383

SponsorTehran University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-08

View on ClinicalTrials.gov More Oral Mucositis trials