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Palonosetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy in children: a double-blind, randomised, comparative trial

Palonosetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy in children: a double-blind, randomised, comparative trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008981
Enrollment
Unknown
Registered
2016-08-05
Start date
2016-08-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

chemotherapy-induced nausea and vomiting

Interventions

1:10ug/kg palonosetron on day 1
2:20ug/kg palonosetron on day 1
3:10ug/kg palonosetron every oher day
4:20ug/kg palonosetron every oher day

Sponsors

Childrens Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: No chemotherapy contraindicated based on blood routine, hepatic and renal function and electrocardiogram examination; no history of other related antiemetics; expected survival time more than 3 months.

Exclusion criteria

Exclusion criteria: Patients with radiotherapy during study; patients with digestive tract obstruction; patients with severe kidney disease, heart disease, metabolic disorders; patients with epilepsy or using psychotropic drugs and narcotics; patients who had received any drug with a potential antiemetic effect in the 24 h before treatment initiation or CINV was observed prior to chemotherapy; patients with brain metastases; vomiting caused by intracranial pressure; patients allergic to 5-HT3 RA; patients have contraindications to chemotherapy; patients with baseline prolongation of the QTc interval of more than 460 ms

Design outcomes

Primary

MeasureTime frame
incidence of nausea;incidence of vomiting;Safety evaluation;

Countries

China

Contacts

Public ContactYang Chao

Childrens Hospital of Chongqing Medical University

yangchao@cqmu.edu.cn+86 18580820414

Outcome results

None listed

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