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临床试验/CTRI/2020/02/023589
CTRI/2020/02/023589招募中未知

COMPARATIVE STUDY OF LOW DOSE VERSUS STANDARD DOSE OF OLANZAPINE AS AN ADD-ON IN CONTROL OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING IN PATIENTS RECEIVING MODERATELY EMETOGENIC CHEMOTHERAPY - LONCIV

Sandip Mukhopadhyay0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Chemotherapy patients with age >= 18 years up to 80 years from both genders with histologically proven malignancy who have been offered high or moderately emetogenic chemotherapy.
  • 2.Acceptable hepatic function (serum bilirubin < 3mg/dl and transaminase < 3X upper limit of normal).
  • 3.Acceptable renal function (Serum creatinine < 2mg/dl and/or Creatinine clearance >= 50ml/min).
  • 4.No nausea in the previous 24 hours of starting the therapy.
  • 5.Absolute neutrophil count >1500/ dl
  • 6.Education level at least 5th standard.
  • 7.Life expectancy 4 months or more.

排除标准

  • 1.CNS disorders e.g. seizure, unstable brain metastasis.
  • 2.Serious cardiac arrhythmia or dysfunction, congestive heart failure (CHF), recent myocardial infarction (MI).
  • 3.Any uncontrolled severe concurrent illness or uncontrolled diabetes.
  • 4.Gastric outlet obstruction, intestinal obstruction.
  • 5.Vomiting within the last 24 hours before study drug administration.
  • 6.Hypersensitivity to any of the study drugs.
  • 7.Patients who received any cancer chemotherapy within the previous 3 weeks.
  • 8.Patients who received any anti-emetic, corticosteroid or any other drug that may influence the study within previous 24 hours.
  • 9. Treatment with any antipsychotic drugs in previous 30 days of start of study,
  • 10.Use of any other investigational drug and participation in any other study within 30 days of study enrollment.

研究者

发起方
Sandip Mukhopadhyay

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