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One Day Antiemetic Prophylaxis of Dexamethasone and Netupitant Plus Palonosetron to Prevent Chemotherapy-induced Nausea and Vomiting

Dexamethasone sparing anti-emetic regimen: One Day Antiemetic Prophylaxis of Dexamethasone & NEPA (Netupitant Plus Palonosetron) to prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Cancer Patients Receiving an HEC Regimen - not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064098
Enrollment
1000
Registered
2024-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: C801- Malignant (primary) neoplasm, unspecified

Interventions

Intervention1: Dexamethasone & NEPA (Netupitant Plus Palonosetron): Oral Dexamethasone plus 300 mg Netupitant plus Palonosetron 0.5 mg on day 1 of each cycle. Control Intervention1: Not Applicable: no

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Willing to give Informed Consent confirmed diagnosis of Cancer ECOG performance status 0 to 2 Acceptable Hepatic and Renal function Parenteral Chemotherapy based on NCCN 2023

Exclusion criteria

Exclusion criteria: pregnant and lactating women Myocardial Infarction within last 6 months Known hypersensitivity to 5HT3RA or NK1RA and excipients Uncontrolled Diabetes Mellitus Nausea and vomiting at baseline Active peptic ulcer

Design outcomes

Primary

MeasureTime frame
no emetic episode & no use of rescue medicationTimepoint: from day 1 to day 5 after HEC administration for maximum of 4 cycles

Secondary

MeasureTime frame
Percentage of emesis-free patientsTimepoint: acute delayed & all single days of all CT cycles upto 4 cycles;Acute delayed & overall nauseaTimepoint: Acute delayed overall & all single days of CT cycles up to 4 cycles;Rescue medicationTimepoint: total duration of study;acute & delayed phase complete response of emesisTimepoint: acute phase 0 to 24 hours delayed phase 24 to 120 hours;complete control of nauseaTimepoint: acute phase 0 to 24 hours delayed phase 24 to 120 hours

Countries

India

Contacts

Public ContactDr Sandeep Batra

Max Super Speciality Hospital Saket (A unit of Devki Devi Foundation)

sandeepriya2000@yahoo.com9811035061

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026