Comparing Single-Day Versus Multi-Day Steroid Treatment for Prevention of Chemotherapy-Induced Nausea and Vomiting in Head and Neck Cancer Patients Receiving Cisplatin-Based Chemotherapy.

A Randomized Prospective Open Label Study comparing single day dexamethasone versus standard dose of dexamethasone containing antiemetic regimen using NEPA in Patients Receiving Cisplatin Based Chemotherapy in patients with Head and Neck cancer - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106844

Enrollment

150

Registered

2026-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Single Day Dexamethasone Antiemetic Regimen with NEPA: Single-Day Dexamethasone Study Group: Day 1: Fixed Dose combination: Netupitant 300mg + Palonosetron 0.5mg. Day 1: Dexamethasone 8

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 years or older. Histologically confirmed Head and Neck malignancy planned for Cisplatin based chemotherapy concurrent with radiation. Histologically confirmed Head and Neck malignancy planned for Cisplatin based chemotherapy in combination with Nanosomal Taxane Paclitaxel or Docetaxel and or Cetuximab or Immunotherapy. ECOG performance status Zero to Two. Adequate organ function. Written informed consent obtained.

Exclusion criteria

Exclusion criteria: Prior chemotherapy within 6 months Known hypersensitivity to medication Pre-existing uncontrolled nausea/vomiting Pregnant Women

Design outcomes

Primary

Measure	Time frame
Complete Response (CR) No emesis and no rescue therapy Complete Protection (CP) CR plus no significant nausea Complete Control (CC) CR plus no nauseaTimepoint: Baseline (before initiation of chemotherapy on Day 1); Acute phase: 0-24 hours after chemotherapy; Delayed phase: 24-120 hours after chemotherapy; Overall phase: each cycle visit (minimum 4 cycles, up to 8 weeks or more).	—

Secondary

Measure	Time frame
Baseline (before chemotherapy on Day 1) Day 1 to Day 7 Patient diary recording End of each chemotherapy cycle End of study (up to 8 weeks / minimum 4 cycles)Timepoint: Baseline (Day 1 before chemotherapy); At 4 weeks (after 2nd chemotherapy cycle); At 8 weeks (after 4th chemotherapy cycle); Across all planned cycles.	—

Countries

India

Contacts

Public ContactDr Kshitij Domadia

HCG Aastha Cancer Centre

krdomadia@gmail.com9871218364

Outcome results

None listed

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