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

Evaluation of oral N-acetylcysteine efficacy versus placebo in prevention of mucositis induced by radiotherapy and chemotherapy agents in children with malignancy A double blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210622051666N1
Enrollment
80
Registered
2023-07-02
Start date
2023-07-23
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

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

Interventions

Intervention 1: Intervention group: Patients treated with N-acetylcysteine tablets (200 mg) produced by a pharmaceutical company. The intervention group started the treatment on the first day with a d

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepideh Dadfar

Ahvaz University of Medical Sciences

dadfar.s@ajums.ac.ir+98 61 3311 0000

Outcome results

None listed

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