| 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
|
|
|
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
|
|
|
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
|
|
|
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. |