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CTRI Number  CTRI/2025/06/089035 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 17/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal 
Study Design  Other 
Public Title of Study   Comparing Different Anti-emetic regimens for prevention of chemotherapy induced nausea and vomiting in newly diagnosed Breast Cancer 
Scientific Title of Study   Comparison of Dexamethasone sparing regimens with NEPA (Neupitant/Palonosetron) versus Dexamethasone containing antiemetic therapy for prevention of chemotherapy induced nausea and vomiting in Breast Cancer patients receiving Anthracycline and Cyclophosphamide 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 Tarun Tomar 
Designation  DM registar  
Affiliation  Kasturba Medical College and Hospital 
Address  4th floor, No: 03, Department of Medical Oncology Shiri Saibaba Cancer Hospital, near Tiger circle Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9720062225  
Fax    
Email  tarun.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tarun Tomar 
Designation  DM registar  
Affiliation  Kasturba Medical College and Hospital 
Address  4th floor, No: 03, Department of Medical Oncology Shiri Saibaba Cancer Hospital, near Tiger circle Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9720062225  
Fax    
Email  tarun.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Tarun Tomar 
Designation  DM registar  
Affiliation  Kasturba Medical College and Hospital 
Address  4th floor, No: 03, Department of Medical Oncology Shiri Saibaba Cancer Hospital, near Tiger circle Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9720062225  
Fax    
Email  tarun.kmcmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
No: 01, 4th floor, Department of Medical Oncology, Shridi saibaba cancer block, Kasturba Medical College and Hospital, Manipal - 576104, Udupi, Karnataka, India 
 
Primary Sponsor  
Name  Dr Tarun Tomar 
Address  4th floor, No: 5, Department of Medical Oncology, Shiridi saibaba cancer hospital,near tiger circle, kasturba medical college and hospital, manipal. 
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 Tarun Tomar  KMC Manipal  Room no. 4, Department of Medical Oncology, Shridi Cancer Block, Kasturba Medical College, MAHE, Manipal - 576104
Udupi
KARNATAKA 
9720062225

tarun.oncology.001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients diagnosed with breast cancer and receiving Anthracycline and cyclophosphamide-based highly emetogenic chemotherapy
Adequate Organ function -serum creatinine less than 2.0 mg/dL; serum bilirubin less than 2.0 mg/dL; serum glutamic-oxaloacetic transaminase or serum glutamic-pyruvic transaminase less than or equal to three or more times the upper limits of normal; absolute neutrophil count greater than 1,500 mm3b)  
 
ExclusionCriteria 
Details  Patients with nausea in the 24 hours before beginning chemotherapy;

Concurrent radiation therapy;

Patients suffering from tumors with brain metastasis/ or with serious psychiatric conditions;
Acutely ill patients such with serious liver and renal disorders and serious cardiac disorders with left ventricular ejection fraction less than 50%;
Pregnant and lactating women;
Unable or refused to cooperate in the evaluation form of nausea and vomiting.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Rating of nausea and vomiting will be by using MAT tool and CTCAE version 5.0
The proportion of patients achieving Overall complete response, Complete response during acute phase, Complete response during delayed phase, Overall complete protection, and No nausea 
At baseline and 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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)   07/07/2025 
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="1"
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  

 

After obtaining IEC clearance and CTRI registration, eligible criteria patients will be included in this study. A structured data collection proforma will be used to enter the patient details, such as age, gender, comorbidities, and physical examination. Since it is the department standard protocol for chemotherapy-induced nausea and vomiting (CINV), we are observing the efficacy of two different treatments for CINV. Patients will be assigned to a dexamethasone-containing and dexamethasone-sparing anti-emetic regimen according to physician discretion.Patients receiving a dexamethasone-sparing regimen will be given dexamethasone only on the day of chemotherapy, along with NEPA on the same day, while patients receiving a dexamethasone-containing regimen will be given dexamethasone from days 1 to 4.The data regarding CINV will be collected on the next visit of the patient to the hospital.Patients are allowed to take rescue medication throughout the study period for nausea or vomiting, if necessary. The choice of recommended rescue medicine will be made from metoclopramide, domperidone, and gabapentin, and the same will be informed at the next visit.The period of assessment for CINV will be done within the first 24 hours after the administration of chemotherapy (acute chemotherapy-induced emesis) and after the initial 24-h period from the 2nd to the 5th day after chemotherapy (delayed emesis).Response Rate will be defined as: Overall complete response (CR-O), defined as no vomiting and no need for rescue medication, at cycle 1 (Time frame: 0–120 h) Complete response during acute phase (CR-AP), defined as no vomiting and no need for rescue medication, at cycle 1 (Time frame: 0–24 h) and Complete response during delayed phase (CR-DP), defined as no vomiting and no need for rescue medication, at cycle 1 (Time frame: 24–120 h). Overall complete protection (CP-O), defined as no significant (< 2.5 mm on VAS) nausea, no and no use of rescue medication (time frame: 0–120 h). No nausea: complete absence of nausea (VAS score 0).Rescue medication is defined as any medication taken in addition to prophylactic treatment for control of nausea or vomiting. In case of any vomiting or nausea, patients will be asked to call the principal investigator by phone, and the rescue medication will be prescribed by the principal investigator.CINV will be assessed by:MAT tool (MASCC Assessment Tool) questionnaire:The translation process highlighted by the MASCC guidelines was followed, and Kannada translation was done by a bilingual translator and was verified by a second translator independently. CTCAE (define the grades 1-4)


 
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