In patients with cancer receiving medicines this is a study trying reduce vomiting sensations

Phase 2

Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Registration Number: CTRI/2024/07/071163

Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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