Using Dolasetron to Prevent Nausea and Vomiting in Children with 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
This study is testing if dolasetron can help prevent nausea and vomiting in children with leukemia who are receiving chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Anhui Provincial Children's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06756022 on ClinicalTrials.gov |
What this trial studies
This observational study involves 500 children aged 2 to 17 years diagnosed with acute lymphoblastic leukemia who will receive dolasetron mesylate injection to prevent chemotherapy-induced nausea and vomiting. Participants will be monitored for nausea and vomiting control within 120 hours after chemotherapy and for safety within 7 days post-treatment. Data on demographics, medical history, and treatment responses will be collected to evaluate the effectiveness of dolasetron in this population.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 17 years diagnosed with acute lymphoblastic leukemia who are starting their first round of induction chemotherapy.
Not a fit: Patients with allergies to dolasetron mesylate or those with prolonged QTc intervals may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for children undergoing chemotherapy by reducing nausea and vomiting.
How similar studies have performed: Previous studies have shown positive outcomes with similar antiemetic approaches, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 2\~17 years old 2. The diagnosis of acute lymphoblastic leukemia was analyzed by comprehensive examination of bone marrow cell morphology, immune typing, cytogenetics and molecular biology. 3. The subjects plan to receive induced remission therapy such as VDLP/VDLD+CAM, multicenter CCCG ALL 2015 protocol, SCCCG-ALL-2023 protocol, etc. according to Guidelines for Diagnosis and Treatment of Childhood acute lymphoblastic Leukemia (2018 Edition) for the first time 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2 5. Expected to survive for more than 3 months 6. Subject or guardian can read, understand and complete subject diary. Exclusion Criteria: 1. Allergic to Dolasetron mesylate injection and its excipients 2. Patients with prolonged QTc interval (QT interval ≥460 ms) 3. Other conditions considered by the researchers not to be included in the group.
Where this trial is running
Hefei, Anhui
- Anhui Children's Hospital — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Tianping Chen
- Email: anhuichentp@163.com
- Phone: （+86）13855189560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.