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临床试验/CTRI/2016/01/006555
CTRI/2016/01/006555进行中(未招募)未知

A prospective observational study of Chemotherapy Induced Nausea Vomiting (CINV) in patients receiving Anthracycline based chemotherapy for Breast Cancer

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 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

排除标准

  • 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

研究者

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