Evaluating the efficacy of N-acetylcysteine mouthwash on the prevention of HSCT-induced mucositis

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N42

Enrollment

100

Registered

2024-09-14

Start date

2024-09-21

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: oral mucositis. Condition 2: hematopoietic stem cell transplantation. Oral mucositis (ulcerative) Stem cells transplant status

Interventions

Intervention 1: Intervention group: Every 6 hours, 600 mg N-acetylcysteine ??as a mouthwash for 14 days or until engraftment. Intervention 2: Control group: Placebo mouthwash every 6 hours for 14 days

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients undergoing hematopoietic stem cell transplantation (allogeneic and autologous) Patients aged between 18 to 65 The requirement to obtain informed consent from patients

Exclusion criteria

Exclusion criteria: History of allergy to N-acetylcysteine ??or any of the side components of effervescent tablets Lack of ability of the patient to adhere to the correct use of mouthwash (such as the possibility of not observing the timing and continuity of use or swallowing after local use) Systemic treatment with N-acetylcysteine ??(oral or injection) Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Incidence of oral mucositis. Timepoint: Daily for 14 days or until engraftment. Method of measurement: Clinical examination.;Incidence of N-acetylcysteine side effects ??(including non-immune anaphylaxis reactions, cardiovascular reactions, skin reactions, gastrointestinal reactions). Timepoint: Daily for 14 days or until engraftment. Method of measurement: Clinical examination.;Severity of mucositis. Timepoint: Daily for 14 days or until engraftment. Method of measurement: Patient examination and grading according to the "oral toxicity scale" of the World Health Organization (WHO).	—

Measure

Time frame

Incidence of oral mucositis. Timepoint: Daily for 14 days or until engraftment. Method of measurement: Clinical examination.;Incidence of N-acetylcysteine side effects ??(including non-immune anaphylaxis reactions, cardiovascular reactions, skin reactions, gastrointestinal reactions). Timepoint: Daily for 14 days or until engraftment. Method of measurement: Clinical examination.;Severity of mucositis. Timepoint: Daily for 14 days or until engraftment. Method of measurement: Patient examination and grading according to the "oral toxicity scale" of the World Health Organization (WHO).

—

Secondary

Measure	Time frame
Length of hospitalization. Timepoint: Until discharge. Method of measurement: Refer to patient file.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMotahareh Tahmasebi

Tehran University of Medical Sciences

mtahmasebi.1999@gmail.com02164120

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026