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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-18

Study Completion Date

2026-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Oral Mucositis Hematopoietic Stem Cell Transplantation (HSCT)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

N-Acetylcysteine 600mg/tab

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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NAC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No