CTRI/2016/01/006555
Active, not recruiting
未知
A prospective observational study of Chemotherapy Induced Nausea Vomiting (CINV) in patients receiving Anthracycline based chemotherapy for Breast Cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Breast Carcinoma
- Sponsor
- Tata Memorial Centre
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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