Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Tab Olanzapine 10 mg OD x 4 days: All subjects will receive the following standard regime of triple antiemetics during chemotherapy (5,11):
Aprepitant 125 mg D1, 80 mg D2-D3
Ondansetron
Sponsors
No Funding Available
Eligibility
Inclusion criteria
Inclusion criteria: This study will include patients receiving doxorubicin and cyclophosphamide regimen in the adjuvant setting and those who were on olanzapine as one of the antiemetic prophylaxis: Adults aged 18 years and above; Chemotherapy-naive breast cancer of any stage; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (19); Written informed consent; Able to understand and describe patient-reported outcomes. Subjects who were on medications such as antibiotics and motility enhancers such as metoclopramide shall be included after a washout period of 7 days.
Exclusion criteria
Exclusion criteria: This study will exclude the following subjects: Scheduled to receive abdominal or pelvic radiotherapy within 8 days of Day 1 of the study; Acute surgical conditions such as gastrointestinal obstruction, appendicitis, and pancreatitis; History of hypersensitivity or allergy to any of the study drugs or similar compounds; Symptomatic brain metastasis, or gastrointestinal tumours; Liver and renal function derangements; Left ventricular ejection fraction Documented Parkinsonââ?¬•s disease; Patients on antipsychotic drugs such as chlorpromazine, risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone; Patients on antiepileptic drugs; Pregnant or breastfeeding women and women of childbearing potential, as well as men wishing to father children; Habitual smoking; History of using any of the following drugs within 48 h before enrolment: opioids, aprepitant, 5-HT3-RA, dexamethasone, dopamine receptor antagonists, antihistamines, benzodiazepines or phenothiazine antipsychotic agents.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are complete response rates in the acute phase (0 ââ?¬â?? 24 h), delayed phase (24 ââ?¬â?? 120 h) and the overall phase (0 ââ?¬â?? 120 h); time to treatment failure; and selected adverse reactions due to the regimen.Timepoint: The secondary outcomes are complete response rates in the acute phase (0 ââ?¬â?? 24 h), delayed phase (24 ââ?¬â?? 120 h) and the overall phase (0 ââ?¬â?? 120 h); time to treatment failure; and selected adverse reactions due to the regimen. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is complete response (proportion of patients do not report nausea and vomiting) within 120 hours (05 days) after initiation of chemotherapy.Timepoint: The primary outcome is complete response (proportion of patients do not report nausea and vomiting) within 120 hours (05 days) after initiation of chemotherapy. | — |
Countries
India
Contacts
Public ContactThinley Dorji
Armed Forces Medical College
Outcome results
None listed