Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: 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,
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 pyridoxineTimepoint: From the 0 to 120 hours of 2nd chemotherapy cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 pyridoxineTimepoint: 5 days | — |
Countries
India
Contacts
Public ContactSai Kiran
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed