To compare the two dosages of Palonosetron(5mcg/kg Vs 20mcg/kg) for the prevention of chemotherapy-induced nausea and vomiting in children with cancer

Comparison of two dosages of palonosetron for the prevention of chemotherapy-induced nausea and vomiting in children and adolescents with cancer receiving moderately or highly emetogenic chemotherapy: A randomized controlled pilot trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082950

Enrollment

100

Registered

2025-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Different dosages of Palonosetron

5mcg/kg Vs 20mcg/kg

IV: Different dosages of Palonosetron

IV Intervention2: Palonosteron , 5mcg/kg: Palonosteron 5mcg/kg intravenous, 30minutes before chemotherapy for prevention of chemotherapy Patients will be included in the study when chemotherapy is s

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children and adolescents with newly diagnosed cancer (chemotherapy-naive) aged between 6 months to 18 years. 2. Receiving moderately or highly emetogenic chemotherapy.

Exclusion criteria

Exclusion criteria: 1.Patients with vomiting, retching, or nausea within 24 hours before starting chemotherapy due to any other cause will be excluded. 2.Children with brain tumors or those who will be receiving concurrent radiotherapy, those with preexisting hepatic, renal, or cardiovascular impairment, or if they had received anticonvulsants, sedatives, or antiemetics 24 hours before chemotherapy. 3.Those with organic disorders likely to cause vomiting (such as seizure disorder, active infection, and surgical conditions like intestinal obstruction) will be excluded. 4.If any patient is receiving serotonergic drugs such as Selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI), Triptans will be excluded because of Serotonin syndrome.

Design outcomes

Primary

Measure	Time frame
1. To compare the efficacy of 5mcg/kg of palonosetron against 20mcg/kg as CINV prophylaxis in children with cancer receiving moderately or highly emetogenic chemotherapy to prevent acute as well as delayed CINV. Timepoint: 2 years	—

Secondary

Measure	Time frame
To compare the adverse effects profile of the 5 mcg/kg palonosetron dose with that of the 20 mcg/kg dose of palonosetron in preventing CINV in children with cancer receiving moderately or highly emetogenic chemotherapy Timepoint: 2 years	—

Countries

India

Contacts

Public ContactPakkiresh Reddy

AIIMS

drnarendrapgi@rocketmail.com9443350635

Outcome results

None listed

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