| 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
|
|
|
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
|
|
|
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)
|