Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Olanzapine, Palonosetron, Dexamethasone and Fosaprepitant.: Day 1. Olanzapine 5 mg PO once. Palonosetron 0.25 mg IV once. Dexamethasone 12 mg IV once. Fosaprepitant 150 mg IV once.
Day
Sponsors
Cancer Institute (W.I.A)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 80 years. 2. Female patients diagnosed with breast cancer. 3. Receiving single-day Adriamycin (60 mg/m2) and Cyclophosphamide (600 mg/m2) (AC) q 2 weekly or 3 weekly for breast cancer in the adjuvant, neoadjuvant or palliative setting. 4. Chemotherapy naïve. 5. Absence of nausea or vomiting 24 hours before enrollment. 6. Eastern Cooperative Oncology Group performance status of 0, 1, or 2. 7. Adequate organ function as confirmed by laboratory investigations within 2 weeks [Aspartate transaminase (AST) and Alanine transaminase (ALT) within 5 times the upper limit of normal (ULN), serum bilirubin less than 2 mg/dL, serum creatinine within ULN]. 8. Hb > 7 gms%, WBC > 4000/cumm, and platelets >100,000/cumm. 9. Women enrolled in the trial need to have a negative pregnancy test within seven days of enrollment and continue to practice contraception during the study period. 10. Written informed consent before enrollment.
Exclusion criteria
Exclusion criteria: 1. Pediatric patients (age less than 18 years) 2. Patients receiving multi-day chemotherapy in a chemotherapy block. 3. Patients receiving steroids as part of the chemotherapy regimen or needed as pre-medication for the prevention of allergic reactions. 4. Patients with brain metastasis. 5. Patients receiving radiotherapy. 6. History of allergy to any of the drugs used for anti-emetic prophylaxis. 7. Patients in whom there are contraindications for corticosteroid use like uncontrolled diabetes mellitus, uncontrolled hypertension, and active peptic ulcer disease. 8. Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days before or during the protocol therapy. 9. Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months. 10. History of neurological disorders including seizures and stroke within the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with no episodes of vomiting and no use of rescue medication (complete response [CR]) during the overall period (0 to 120 hours).Timepoint: 0-120 hours from start of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of MD Anderson Symptom Inventory (MDASI) scores between the standard arm and the OLA5 arm and the standard arm and the no-DEX arm.Timepoint: days 0 (before chemotherapy),1,2,3,4, and 5;Comparison of quality of life (QOL) between the standard arm and the OLA5 arm and the standard arm and the no-DEX armTimepoint: day 0 (before chemotherapy) and day 8.;The number of patients with CR for vomiting during the acute period (0 to 24 hours) and the delayed period (24-120 hours).Timepoint: 0-24 hours and 24-120 hours from start of chemotherapy.;The number of patients with CR to nausea for the overall, acute, and delayed period.Timepoint: 0-24 hours (acute period), 24-120 hours (delayed period) and 0-120 hours (overall period) from start of chemotherapy;The number of patients with CTCAE grade 1 to 5 adverse eventsTimepoint: Till day 8 of chemotherapy | — |
Countries
India
Contacts
Public ContactVenkatraman Radhakrishnan
Cancer Institute (W.I.A)
Outcome results
None listed