| CTRI Number |
CTRI/2025/10/096354 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pyridoxine to reduce nausea in patients reciveing chemotherapy for cancer |
|
Scientific Title of Study
|
Pyridoxine in Prevention of Nausea in Patients on Highly Emetogenic Chemotherapy: A Phase III, Randomized, Double-blind, Placebo-controlled Trial (PiN-II Trial) |
| Trial Acronym |
PiN-II |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/IECIS-6/0725/95 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanth Ganesan |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Medical Oncology 3rd Floor SS Block JIPMER
Dhanwantry Nagar Gorimedu Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444216310 |
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanth Ganesan |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Medical Oncology 3rd Floor SS Block JIPMER
Dhanwantry Nagar Gorimedu Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444216310 |
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasanth Ganesan |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Medical Oncology 3rd Floor SS Block JIPMER
Dhanwantry Nagar Gorimedu Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444216310 |
| Fax |
|
| Email |
pg1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanwantri Nagar, Puducherry-605006
India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER |
| Address |
Dhanwantry Nagar Gorimedu Puducherry-605006
India |
| Type of Sponsor |
Research institution |
|
|
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 Prasanth Ganesan |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Medical Oncology, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY |
9444216310
pg1980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (2) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (3) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Oral Placebo tablet twice a day for 4 days(containing starch) will be given to participants in the control arm (Arm B) along with the 4 drug anti emetic prophylaxis regimen consisting of olanzapine, NK 1 antagonist, 5 HT 3 antagonist, and dexamethasone in standard doses |
| Intervention |
Pyridoxine |
Pyridoxine 40 mg twice a day for 4 days will be given to participants in the intervention arm (Arm A) along with the 4 drug anti emetic prophylaxis regimen consisting of olanzapine, NK 1 antagonist, 5 HT 3 antagonist, and dexamethasone in standard doses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age is greater than or equal to 18 years.
2.Diagnosed with malignancy of any stage.
3.Planned to receive the first cycle of highly emetogenic chemotherapy.
4.Chemotherapy regimens must be highly emetogenic drugs on Day 1 of the cycle and have no chemotherapy on Days 2 through 4.
5.Patients must be planned for standard anti-emetic prophylaxis with a four-drug combination.
6.ECOG performance status of 0 to 2 at the time of enrolment.
7.Negative serum or urine pregnancy test in women of childbearing potential.
8.Adequate blood counts and organ functions (within 4 weeks of chemotherapy administration). This includes:
Hemoglobin greater than or equal to 7 g/dL.
WBC counts: greater than or equal to 4000 per cmm or Absolute neutrophil count greater than or equal to 1500 per cmm.
Platelet counts: greater than or equal to 100,000 per cmm.
Total Bilirubin less than or equal to 2 times ULN.
AST (SGOT) less than or equal to 3 times ULN.
ALT (SGPT) less than or equal to 3 times ULN.
Serum creatinine less than or equal to 2 mg/dL |
|
| ExclusionCriteria |
| Details |
1.Prior radiation and/or chemotherapy for current cancer diagnosis or any other cancer in the past.
2.Use of a dose of steroid other than dexamethasone.
3.Use of a dose of dexamethasone which is higher than what is planned in this study.
4.Chronic alcoholism, as determined by the investigator.
5.Organ dysfunction which prevents safe delivery of medications.
6.Concurrent use of radiation is planned (unless planned to be started greater than or equal to 1 week after cycle 1 day 1).
7.Refusal of consent.
8.Unable to answer phone calls or cooperate with other study-related activities.
9.Use of psychotherapy and/or sedative medications that can interact with the antiemetic agents.
10.Serious intercurrent illness or medical condition such as active uncontrolled infection, uncontrolled diabetes, or significant cardiac dysfunction.
11.Known history of brain metastatic disease or seizure disorders.
12.Use of concurrent quinolone antibiotics or amifostine.
13.Human Immunodeficiency Virus (HIV) infection and/or Anti-retroviral therapy and/or Hepatitis C Virus (HCV) infection (unless treated with an undetectable viral load).
14.Active Hepatitis B infection.
15.Patients with baseline nausea and vomiting due to underlying disease or any other cause. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| “no nausea” rates in the overall period (0-120 hours) |
0-120 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
No nausea rates in the acute (0-24 hours) & delayed (24-120 hours) periods.
Control of emesis, defined as a complete response (no vomiting & no use of rescue medicines), in the acute (0-24 hours), delayed (24-120 hours), & overall (0-120 hours) periods.
Severity of nausea, measured using a visual analogue scale.
Complete control (CC), defined as no emetic episodes, no use of rescue medication, & no more than mild nausea (less than 3 on a VAS scale of 0-10).
Adverse events attributable to the investigational product.
Assessment of emesis by the Functional Living Index (FLI-E).
Adherence to the regimen. |
6 days |
|
|
Target Sample Size
|
Total Sample Size="372"
Sample Size from India="372"
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 3 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="2"
Months="0"
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 randomised double blind study to be conducted among adult patients with cancer planned to start the first cycle of chemotherapy with high risk of vomiting and nausea. The study will compare the control of nausea in the overall period (from 0-120 hours) between arm A and arm B. In arm A patients will receive standard 4 drug anti emetic prophyalxis with pyridoxine 40 mg BD for 4 days. In arm B, patients will receive standard 4 drug anti emetic prophylaxis wtih placebo for 4 days. The standard 4 drug regimen will consist of olanzapine, neurokinin blocker, 5 ht 3 antagonist, and dexamethasone. The secondary end points will be control of emesis, adherence, and quality of life and adverse events. The study will be conducted in India over 6 centers.
|