| CTRI Number |
CTRI/2025/12/098653 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of two medicines to stop vomiting caused by strong chemotherapy |
|
Scientific Title of Study
|
A Randomized open label Study Comparing the Efficacy of
Aprepitant-Olanzapine Versus Netupitant-Palonosetron Therapy
for Controlling CINV in Patients Receiving Highly Emetogenic
Chemotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Mahlawat |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Govt Medical College |
| Address |
Pharmacology Department, Para-clinical Block, Dr. Rajendra Prasad
Government Medical College, Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
07339778379 |
| Fax |
|
| Email |
nidhimehlawat@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Sood |
| Designation |
Professor & Head |
| Affiliation |
Dr Rajendra Prasad Govt Medical College |
| Address |
Pharmacology Department Para-clinical Block Dr Rajendra Prasad
Government Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418063191 |
| Fax |
|
| Email |
Atalsood7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atal Sood |
| Designation |
Professor & Head |
| Affiliation |
Dr Rajendra Prasad Govt Medical College |
| Address |
Pharmacology Department Para-clinical Block Dr Rajendra Prasad
Government Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418063191 |
| Fax |
|
| Email |
Atalsood7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad Government Medical College, Kangra at Tanda, H.P., India, PIN: 176002 |
|
|
Primary Sponsor
|
| Name |
Pharmacology Department Paraclinical Block Dr RPGMC Kangra at Tanda HP India |
| Address |
Pharmacology Department, Para-clinical Block, Dr. R.P.G.M.C.,
Kangra at Tanda |
| Type of Sponsor |
Government medical college |
|
|
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 Nidhi Mahlawat |
Dr. Rajendra Prasad Government Medical College |
Room No. 15,
Department of
Radiotherapy &
Oncology and Room
No. 815, Department of
Pharmacology
Kangra
HIMACHAL PRADESH |
07339778379
nidhimehlawat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr rajendra prasad govt medical college(Dr.RPGMC) Kangra at Tanda, Himachal Pradesh- 176001 Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aprepitant + Olanzapine |
Aprepitant 125 mg orally on Day 1, followed by 80 mg orally on Days 2–3, plus Olanzapine 5 mg orally once daily on Days 1–4, administered as pre-medication before first chemotherapy cycle only. |
| Comparator Agent |
Netupitant + Palonosetron |
Fixed-dose combination of Netupitant 300 mg + Palonosetron 0.5 mg given orally as a single dose on Day 1, administered as pre-medication before first chemotherapy cycle only. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Willing adult patient giving written informed consent.
Normal routine blood investigations |
|
| ExclusionCriteria |
| Details |
Patient not willing to give written informed consent.
Pregnant and Lactating females.
Patient already on treatment with study drug.
Patients with known contraindication or refractoriness to study drugs. |
|
|
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) to antiemetic therapy, defined as no vomiting and no use of rescue medication during:
• Acute phase (0–24 hours) after chemotherapy
• Delayed phase (24–120 hours) after chemotherapy |
Baseline, 24 hours, and 120 hours after chemotherapy in first cycle. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Chemotherapy-induced nausea and vomiting (CINV) is one of the most distressing adverse effects experienced by patients receiving highly emetogenic chemotherapy such as cisplatin. Uncontrolled CINV can result in poor nutritional intake, dehydration, reduced treatment compliance, and diminished quality of life. Effective antiemetic therapy is therefore essential to improve tolerance and treatment outcomes.
Aprepitant combined with Olanzapine and the fixed-dose combination of Netupitant-Palonosetron are both recommended regimens for prevention of CINV; however, their comparative efficacy in patients receiving cisplatin-based chemotherapy remains an area of active research. This randomized open-label study evaluates the effectiveness of these two antiemetic regimens in preventing acute and delayed CINV.
The findings from this study may support optimization of antiemetic strategies, improve patient comfort, and enhance adherence to cancer treatment. Results obtained will be analyzed statistically and shared through scientific publication to contribute to clinical practice improvements. |