Evaluation of oral N-acetylcysteine efficacy versus placebo in prevention of mucositis induced by radiotherapy and chemotherapy agents in children with malignancy

Phase 3

Recruiting

Conditions: CHEMOTHERAPY,MUCOSITIS,RADIATION THERAPY,CANCER.
Oral mucositis (ulcerative) due to antineoplastic therapy
K12.31

Registration Number: IRCT20210622051666N1

Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Patients who are 2-18 years old
Recipients of radiotherapy and anti-metabolite chemotherapy drugs with a high risk of developing oral mucositis (including Doxorubicin, Methotrexate, FU Etoposide, Cytarabine and Melphalan) and other drugs listed below.
Patients with lansky performance scale index above 70%
No Cardiovascular disease

Exclusion Criteria

Causes any severe allergic reactions to the drug (such as skin complications, bronchospasm, bronchitis, etc.)
Any active gastrointestinal disease
Cardiovascular disease

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The score of positive and negative symptoms in the PANSS questionnaire. Timepoint: Prevention of mucositis caused by radiotherapy at the beginning of the study (before the start of the intervention) and 7, 15 days after the start of taking N-acetylcysteine. Method of measurement: Questionnaire of positive and negative symptoms of oral mucositis.

Secondary Outcome Measures

Name	Time	Method
The level of the oxidative stress factor Malondialdehyde in the blood. Timepoint: Measurement of the oxidative stress factor Malondialdehyde at the beginning of the study (before the start of the intervention) and 7, 15 days after the start of taking N-acetylcysteine. Method of measurement: Measurement of Malondialdehyde oxidative stress factor in patient's blood by UV spectrophotometry.