Observational study in Breast cancer patient who are taking Anthracyclin Chemotherapy to observe chemotherapy induced nausea and vomiting
- Conditions
- Health Condition 1: null- Breast Carcinoma
- Registration Number
- CTRI/2016/01/006555
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <1,500/mm3, white blood cell count <3,000/mm3, platelet count <100,000/mm3, aspartate transaminase >2.5Ã? upper limit of normal, alanine transaminase >2.5Ã? upper limit of normal, bilirubin >1.5Ã? upper limit of normal, creatinine >1.5Ã? upper limit of normal}.
Asymptomatic metastases to the brain
Seizure disorder needing anticonvulsants unless clinically stable
Intestinal obstruction
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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