The effect of N-acetyl cysteine in preventing mucositis in patients undergoing bone marrow transplantation

The effect of N-acetyl cysteine in preventing the incidence and severity of mucositis in patients undergoing bone marrow transplantation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201303301030N13

Enrollment

Registered

2013-04-10

Start date

2012-11-05

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: Mucositis (oral). Condition 2: AML. Condition 3: ALL. Condition 4: MDS. Oral mucositis (ulcerative) Acute myeloblastic leukaemia Acute lymphoblastic leukaemia Myelodysplastic syndromes

Interventions

Intervention 1: N-acetyl cysteine IV 00mg/kg daily. Intervention 2: Placebo.

Treatment - Drugs

Placebo

N-acetyl cysteine IV 00mg/kg daily

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Patients receiving chemotherapy regimens (Endoxane- busulfan) in bone marrow transplantation. 2- The patient over the 18 years old of age. 3-Informed consent forms signed by the patients. Exclusion: 1- Participating in other clinical trial (drug or supplement) 2- Dissatisfaction of patient.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Oral mucositis. Timepoint: Daily at the first day of chemotherapy until the patients discharged. Method of measurement: Clinical observation.	—

Secondary

Measure	Time frame
Glutathione peroxidase serum level. Timepoint: At the first day of admission and 14 days after the transplantation. Method of measurement: Lab Test (ng/dl).;Fever incidence. Timepoint: Daily until discharg. Method of measurement: Measurement of oral temperature.;Duration of neutropenia. Timepoint: Daily until discharg. Method of measurement: Lab Test.;Consumption of TPN. Timepoint: During Hospitalization. Method of measurement: Medical Records.;Antibiotic consumption. Timepoint: During Hospitalization. Method of measurement: Medical Records.	—

Measure

Time frame

Glutathione peroxidase serum level. Timepoint: At the first day of admission and 14 days after the transplantation. Method of measurement: Lab Test (ng/dl).;Fever incidence. Timepoint: Daily until discharg. Method of measurement: Measurement of oral temperature.;Duration of neutropenia. Timepoint: Daily until discharg. Method of measurement: Lab Test.;Consumption of TPN. Timepoint: During Hospitalization. Method of measurement: Medical Records.;Antibiotic consumption. Timepoint: During Hospitalization. Method of measurement: Medical Records.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Moslehi

Hematology Oncology and SCT Research Center

horcbmt@tums.ac.ir+98 21 8490 2635

Outcome results

None listed

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