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

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 controlled trial

The current clinical trial has two experimental and control groups in parallel. This phase 3 study is a double-blind, randomized study on 100 patients.

This study is conducted at the Research Institute of Oncology, Hematology, and Cell Therapy located in Shariati Hospital. 100 patients were included in the study and divided into two experimental and control groups. Meanwhile, patients, researchers and healthcare providers are not aware of this division. The experimental group received 2400 mg N-acetylcysteine ​​daily and the control group received a placebo daily.

Eligibility criteria: • Patients undergoing HSCT (allogeneic and autologous) • Aged over 18 years • Informed consent of patients Criteria for not entering the study: • History of allergy to N-acetylcysteine ​​or any of the components of effervescent tablets • Lack of ability of the patient to adhere to the correct use of mouthwash •Systemic intake of N-acetylcysteine • Pregnancy or lactation

Intervention group: daily intake of 2400 mg of N-acetylcysteine ​​as a mouthwash Control group: receiving daily placebo in the form of mouthwash

Evaluating the safety and efficacy of N-acetylcysteine ​​mouthwash on reducing the incidence of different degrees of mucositis, especially its severe degrees (grade 3 and 4) in patients undergoing HSCT; Investigating the relationship between prophylactic N-acetylcysteine ​​mouthwash and length of hospitalization after engraftment in these patients; Introducing an effective medication to prevent of mucositis in HSCT; Introducing a potential indication of a product in market

All adult patients who are admitted for hematopoietic stem cell transplantation to the Research Institute for Oncology, Hematology, and Cell Therapy, affiliated with Tehran University of Medical Sciences (TUMS), in the case of being eligible and obtaining informed consent, are included in the study and randomly assigned to Two groups of intervention and placebo. Pateints are parallelly allocated into the two groups. Random list with balanced block, in blocks of four samples and considering the sample size of 100 cases with the following command: ralloc block size treat, nsubj(100) seed(1) saving(mytrial) osize(1) init(4) idvar(study_ID) will be prepared in Stata. The Excel list will include row number, study_ID (including random numbers), and type of intervention (A/B). Group A is considered as intervention group and group B as placebo.

medications were labeled according to the list and according to study_ID generated by a third party. The complete list, including the randomization sequence and study_ID, will be recorded in an Excel file until the end of the study. According to the study_ID list provided to the researcher, when the patient enters the study, the labeled medication will be given to the patient by the researcher. Except for the third party, all members of the research group, including those responsible for evaluating safety, efficacy, collecting information, analyzing data, and the participating patients, are not aware of the type of the received intervention.

There is no further information.