Health Condition 1: null- Breast Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Breast cancer patients receiving first cycle of Anthracycline (Neo) Adjuvant chemotherapy Newly diagnosed Breast cancer patients requiring anthracycline regimens Patients with histologically confirmed invasive breast carcinoma. ECOG PS 0-2 at study entry Age more than 18 years
Exclusion criteria
Exclusion criteria: Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed Patients who had received or were to receive radiation therapy to the abdomen or pelvis in the week prior to treatment Patients who had vomited in the 24 hr prior to treatment or on concurrent intake of any other emetogenic drug or radiotherapy or a known hypersensitivity to 5-HT3-receptor antagonists or dexamethasone Patients who had an active infection or any uncontrolled disease other than malignancy Baseline laboratory values outside the clinically acceptable limits{Abnormal laboratory values (absolute neutrophil count 2.5× upper limit of normal, alanine transaminase >2.5× upper limit of normal, bilirubin >1.5× upper limit of normal, creatinine >1.5× upper limit of normal}. Asymptomatic metastases to the brain Seizure disorder needing anticonvulsants unless clinically stable Intestinal obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To understand the incidence of CINV amongst patients undergoing Anthracycline based or highly emetogenic chemotherapy for breast cancer.Timepoint: To understand the incidence of CINV amongst patients undergoing Anthracycline based or highly emetogenic chemotherapy for breast cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the impact of co varieties on the incidence of CINV amongst patients undergoing Anthracycline based or highly emetogenic chemotherapy for breast cancer.Timepoint: End of 5th day of chemotherapy | — |
Countries
India
Contacts
Tata Memorial Hospital