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CTRI Number  CTRI/2026/03/106844 [Registered on: 24/03/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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. 
Scientific Title of Study   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 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kshitij Domadia 
Designation  Medical Oncologist 
Affiliation  HCG Aastha Cancer Centre 
Address  Medical Oncology Department, 2nd Floor, Cabin No. 4, HCG Aastha Cancer Centre, Opposite Bhagwat Vidyapith, Sola

Ahmadabad
GUJARAT
380060
India 
Phone  9871218364  
Fax    
Email  krdomadia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kshitij Domadia 
Designation  Medical Oncologist 
Affiliation  HCG Aastha Cancer Centre  
Address  Medical Oncology Department, 2nd Floor, Cabin No. 4, HCG Aastha Cancer Centre, Opposite Bhagwat Vidyapith, Sola

Ahmadabad
GUJARAT
380060
India 
Phone  9871218364  
Fax    
Email  krdomadia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kshitij Domadia 
Designation  Medical Oncologist 
Affiliation  HCG Aastha Cancer Centre  
Address  Medical Oncology Department, 2nd Floor, Cabin No. 4, HCG Aastha Cancer Centre, Opposite Bhagwat Vidyapith, Sola

Ahmadabad
GUJARAT
380060
India 
Phone  9871218364  
Fax    
Email  krdomadia@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Kshitij Domadia 
Address  HCG Aastha Cancer Centre, opposite Bhagwat Vidyapith on Science City Road, Off S.G. Highway, Sola, Ahmedabad, Gujarat 380060. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kshitij Domadia  HCG Aastha Cancer Centre  Medical Oncology Department, 2nd Floor, Cabin No. 4, HCG Aastha Cancer Centre, Opposite Bhagwat Vidyapith, Sola
Ahmadabad
GUJARAT 
9871218364

krdomadia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCG Multi Specialty Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 8mg (IV),Day 1-4: Olanzapine 5mg PO QHS  
Comparator Agent  Standard Dexamethasone Containing Antiemetic Regimen with NEPA  Standard Dexamethasone Control Group: Day 1: Fixed Dose combination: Netupitant 300mg + Palonosetron 0.5mg.Day 1-4: Dexamethasone 12mg IV on Day 1, followed by 8mg on day 2,3,4 PO Day 1-4: Olanzapine 5mg PO QHS  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  Prior chemotherapy within 6 months

Known hypersensitivity to medication

Pre-existing uncontrolled nausea/vomiting

Pregnant Women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Complete Response (CR) — No emesis and no rescue therapy Complete Protection (CP) — CR plus no significant nausea Complete Control (CC) — CR plus no nausea  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 Outcome  
Outcome  TimePoints 
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)  Baseline (Day 1 before chemotherapy); At 4 weeks (after 2nd chemotherapy cycle); At 8 weeks (after 4th chemotherapy cycle); Across all planned cycles. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a randomized, prospective, open-label, single-center clinical trial designed to compare the efficacy and safety of a single-day dexamethasone regimen versus a standard multi-day dexamethasone-containing antiemetic regimen in patients with histologically confirmed Head and Neck cancer receiving cisplatin-based chemotherapy.

Cisplatin is associated with a high risk of chemotherapy-induced nausea and vomiting (CINV). Current antiemetic guidelines recommend a combination of an NK1 receptor antagonist, a 5HT3 receptor antagonist, corticosteroids, and olanzapine. However, prolonged corticosteroid use is associated with adverse effects such as hyperglycemia, immunosuppression, insomnia, and psychiatric disturbances. This study aims to determine whether reducing dexamethasone exposure to a single day provides comparable control of CINV while minimizing steroid-related toxicity.

A total of 150 eligible adult patients will be randomized into two parallel arms.

Arm A will receive Netupitant 300 mg plus Palonosetron 0.5 mg on Day 1, Dexamethasone 12 mg intravenous on Day 1 followed by 8 mg orally on Days 2 to 4, and Olanzapine 5 mg orally once daily for four days.

Arm B will receive Netupitant 300 mg plus Palonosetron 0.5 mg on Day 1, Dexamethasone 8 mg intravenous on Day 1 only, and Olanzapine 5 mg orally once daily for four days.

The primary endpoints include complete response, complete protection, and complete control of CINV during acute, delayed, and overall phases following chemotherapy. Secondary outcomes include safety assessment and evaluation of quality of life using the EORTC QLQ-C30 questionnaire.

The study duration is one and a half years, and all procedures will be conducted in accordance with ICMR ethical guidelines and ICH GCP principles.

 
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