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NCT Number: NCT07325383

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Oral Mucositis Hematopoietic Stem Cell Transplantation (HSCT) Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Institute of Oncology, Hematology, and Cell Therapy, Shariati Hospital

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-Acetylcysteine 600mg/tab

Drug

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.

Other names: NAC

Placebo

Drug

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.

Primary outcomes

  1. Incidence of oral mucositis

    Time frame: 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.

  2. Incidence of N-acetylcysteine-related Adverse Events

    Time frame: 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).

  3. Incidence of Severe Oral Mucositis

    Time frame: 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.

Secondary outcomes

  1. Length of Hospitalization

    Time frame: From hospital admission through hospital discharge, up to Day +60 post-transplantation

    The number of days from admission for hematopoietic stem cell transplantation until hospital discharge. Data are obtained from the patients' medical records. This outcome reflects overall clinical recovery and is used to evaluate the potential supportive effect of N-acetylcysteine on hospitalization duration.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences, Iran

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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