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CTRI Number  CTRI/2024/07/071163 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   In patients with cancer receiving medicines this is a study trying reduce vomiting sensations 
Scientific Title of Study   Efficacy and safety of Pyridoxine as add-on therapy in prevention of chemotherapy induced nausea and vomiting in patients of Cancer Breast receiving Epirubicin and Cyclophosphamide (PiN study):A Phase II, single arm study 
Trial Acronym  PiN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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 
Address  Department of Medical Oncology Super Specialty Block 3rd Floor Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9444216310  
Fax    
Email  p.ganesan@jipmer.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Sai Kiran 
Designation  Senior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Medical Oncology Super Specialty Block 3rd Floor Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7795213715  
Fax    
Email  saikirankoner@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sai Kiran 
Designation  Senior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Medical Oncology Super Specialty Block 3rd Floor Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7795213715  
Fax    
Email  saikirankoner@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Dhanvantri Nagar Puducherry 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER 
Address  Dhanwantri Nagar, Puducherry 605006 
Type of Sponsor  Research institution and hospital 
 
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 Prasanth Ganesan  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Department of Medical Oncology 5032 3rd Floor SS Block Dhanwantri Nagar, Gorimedu
Pondicherry
PONDICHERRY 		 9444216310

p.ganesan@jipmer.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Interventional Studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  standard therapy with pyridoxine  Pyridoxine 40mg BD per day is given from day 1 to day 4 of post second chemotherapy cycle along with the standard anti-emetic prophylaxis (Olanzapine, Aprepitant, Ondensetron, Dexamethasone) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Patients receiving first-line therapy with
Receiving Anthracycline or Cyclophosphamide combination
Patients must provide written informed consent including consent for tele-phonic conversation or questionnaire both in the current and next cycle of chemotherapy.
ECOG Eastern Cooperative Oncology Group performance status of 0, 1, and 2 at the time of enrolment in the study
Adequate blood counts and organ functions
ANC more than 1500/cumm
Total Bilirubin less than or equal to 1.5 times ULN
AST (SGOT) less than or equal to 3times ULN
ALT (SGPT) less than or equal to 3times ULN
Serum creatinine less than or equal to 2 mg/dL or a measured creatinine clearance morethan or equal to 40 mL/min according to Cockcroft-Gault formula 
 
ExclusionCriteria 
Details  Nausea or vomiting in the past 24 hours.
Severe neurocognitive impairment.
Known history of central nervous system organic disorder
Known psychiatric disorder
Human Immunodeficiency Virus infectio and or on anti-retroviral therapy and or HCV infection patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study.
Active Hepatitis B infection in patients who are Hepatitis B carriers, the markers of active infection such as HBeAg and HBV DNA titers must be negative, and patients would be continued on appropriate prophylaxis with antivirals throughout the study.
Regular alcohol intake 3 or more drinks equivalent of 45 ml of liquor per week
Known hypersensitivity to the study agents
Known cardiac arrhythmia, uncontrolled CHF, or acute MI within the last 6 months
History of uncontrolled DM 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the no nausea proporation among patients with breast cancer receiving EC chemotherapy when receiving anti-emetic prophylaxis with the combination of standard 4-drug ondansetron, aprepitant, dexamethasone, and olanzapine with add on pyridoxine  From the 0 to 120 hours of 2nd chemotherapy cycle 
 
Secondary Outcome  
Outcome  TimePoints 
Complete response no emetic episode and no use of rescue medications in acute, delayed and overall period
No nausea in acute period 0-24hours
No nausea in delayed period 24-120hours
Adverse events that are possibly due to pyridoxine 		 5 days 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   31/07/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Extent of the problem: Chemotherapy induced nausea and vomiting (CINV) is a common, predictable and preventable acute side effect of chemotherapy and it negatively affects the overall experience of chemotherapy. Recent guidelines recommend four drug regimen of Olanzapine, NK1 receptor antagonist, 5HT3 antagonist and dexamethasone as current standard for preventing chemotherapy induced nausea and vomiting. Despite adherence to standard treatment regimens, some patients continue to experience episodes of nausea and vomiting both in acute and delayed phase. Nausea can have significant negative impact on quality of life of patients. Hence there is a need for improving currently available regimens for CINV prophylaxis.Since pyridoxine is a fairly safe agent and is planned for short term use (4 days per cycle), it is expected to be safe when combined with current anti emetic prophylactic agents. Till date, there is no data on any combination which is superior to the 4-drug regimen for anti CINV prophylaxis. Also, there is limited data on the use of pyridoxine as anti-nausea agent in patients receiving chemotherapy (despite extensive data in hyperemesis gravidarum). 
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