RecruitingNCT06756022

Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia

Prospective, Multicenter, Real-world Study of Dolasetron Mesylate Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children With Acute Lymphoblastic Leukemia

Sponsor

Anhui Provincial Children's Hospital

Enrollment

500 participants

Start Date

Nov 21, 2024

Study Type

OBSERVATIONAL

Conditions

Chemotherapy Induced Nausea and Vomiting

Summary

This is a prospective, multicenter, real-world study of 500 participants with childhood acute lymphoblastic leukemia who are scheduled to receive dolasetron mesylate injection for prophylaxis against chemotherapy-induced nausea and vomiting. This study did not make any decision or process intervention for clinical antitumor therapy. The study plans to observe the control of nausea and vomiting within 120 h (D1-D5) after receiving induction chemotherapy and the safety within 7 days (or until this discharge, whichever occurs first). During the whole study, demographic data, history of motion sickness, ECOG score, complications, name and dosage of anti-tumor therapy drugs, this antiemetic regimen, nausea and vomiting, rescue therapy drugs, combined drugs and adverse events were recorded.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether dolasetron (a medication to prevent nausea and vomiting) is effective and safe for children with acute lymphoblastic leukemia (ALL) who are experiencing nausea and vomiting caused by their chemotherapy. **You may be eligible if...** - Your child is between 2 and 17 years old - Your child has been diagnosed with acute lymphoblastic leukemia (ALL) by bone marrow testing - Your child is starting induction chemotherapy (the first intensive phase of ALL treatment) for the first time - Your child (or guardian) can read and complete a symptom diary - Your child has an ECOG performance score of 0–2 and expected survival of more than 3 months **You may NOT be eligible if...** - Your child has an allergy to dolasetron or its ingredients - Your child has a prolonged QTc interval on an ECG (a heart rhythm abnormality) - Your doctor has other reasons to determine this isn't appropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDolasetron mesylate injection

1.8 mg/kg Dolasetron mesylate injection should be injected intravenously 30±10 min before chemotherapy infusion, with the maximum dose not exceeding 100 mg. It can also be mixed with apple juice or apple-grape juice for oral use, the oral dose is 1.8 mg/kg, the maximum amount is not more than 100 mg, taken orally within 1 h before chemotherapy. Other antiemetic drugs, except dolasetron, are at the discretion of the subject's supervising physician in accordance with clinical practice.