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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Incidence of oral mucositis
研究概览
简要总结
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.
详细描述
This randomized, double-blind, placebo-controlled clinical trial evaluates the safety and efficacy of N-acetylcysteine (NAC) mouthwash in preventing oral mucositis (OM) in patients undergoing hematopoietic stem cell transplantation (HSCT). Oral mucositis is one of the most common and severe complications following HSCT, significantly affecting patient quality of life, treatment adherence, and duration of hospitalization.
A total of 100 patients undergoing autologous or allogeneic HSCT were enrolled and randomly assigned into two parallel groups: an intervention group and a placebo group. The intervention group received 2400 mg of N-acetylcysteine daily as a mouthwash, while the control group received a placebo mouthwash with identical appearance and administration protocol. Both patients and healthcare providers were blinded to group allocation.
The study was conducted at the Research Institute of Oncology, Hematology, and Cell Therapy (RIOHCT), located in Shariati Hospital and affiliated with Tehran University of Medical Sciences. Daily evaluations for the incidence and severity of mucositis were performed using the World Health Organization (WHO) mucositis grading scale.
The primary objective is to assess the efficacy of prophylactic NAC mouthwash in reducing the incidence and severity of OM, particularly grades 3 and 4. Secondary objectives include examining the effect of NAC mouthwash on hospitalization length after engraftment and determining the safety profile of the intervention. Findings from this study may support the introduction of NAC mouthwash as a preventive strategy against mucositis in HSCT patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing hematopoietic stem cell transplantation (HSCT), including both allogeneic and autologous transplants
- •Age ≥18 years
- •Ability to provide informed consent
排除标准
- •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
研究组 & 干预措施
N-Acetylcysteine group
Participants in this group receive 2400 mg of N-acetylcysteine daily as an oral mouthwash, divided into four doses per day. The intervention starts at the beginning of the conditioning regimen and continues until day 14 after hematopoietic stem cell transplantation.
干预措施: N-Acetylcysteine 600mg/tab (Drug)
Placebo group
Participants in this group receive a placebo mouthwash with identical appearance, taste, and administration schedule as the NAC mouthwash. The placebo contains no active pharmaceutical ingredients and is administered four times daily from the start of conditioning until day 14 post-transplantation.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of oral mucositis
时间窗: From day 1 of conditioning to day +14 post-transplantation.
Oral mucositis is a painful and debilitating complication of hematopoietic stem cell transplantation, characterized by erythema, edema, and ulcerations of the oral mucosa. The incidence of mucositis is assessed daily from the beginning of the conditioning regimen until day +14 post-transplantation. The World Health Organization (WHO) Oral Toxicity Scale is used to grade the severity of mucositis. The presence of grade ≥1 mucositis is recorded as incidence.
Incidence of N-acetylcysteine-related Adverse Events
时间窗: Clinical examination is performed daily from the beginning of the conditioning regimen until day +14 post-transplantation.
Participants are monitored daily for any adverse events potentially related to the use of N-acetylcysteine mouthwash. Adverse events include non-immune anaphylaxis reactions, cardiovascular reactions, dermatologic reactions (such as rash or pruritus), and gastrointestinal reactions (such as nausea or vomiting).
Incidence of Severe Oral Mucositis
时间窗: From day 1 of conditioning to day +14 post-transplantation
Severe oral mucositis is defined as grade 3 or 4 according to the World Health Organization (WHO) Oral Toxicity Scale. Participants are assessed daily to determine the presence and severity of mucositis. The incidence of severe mucositis (grade ≥3) is recorded during the study period.
次要结局
- Length of Hospitalization(From hospital admission through hospital discharge, up to Day +60 post-transplantation)
研究者
Bita Shahrami
PharmD, iBCPS, FCCP Assistant; Professor at Tehran University of Medical Sciences (TUMS)
Tehran University of Medical Sciences