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临床试验/CTRI/2024/03/064371
CTRI/2024/03/064371尚未招募3 期

Olanzapine for weight gain for children undergoing chemotherapy for solid malignancies: An Investigator-Initiated, Open-Label, Multi-Center, Phase III Randomized Controlled Trial - SNOWMA

Prof Sameer Bakhshi PI0 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
3 期
状态
尚未招募
发起方

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

  • 1Children and adolescents aged 2 to 18 years at the time of enrolment
  • 2Body weight of atleast 10 kilograms
  • 3Diagnosis of a solid malignancy
  • 4Chemotherapy or Radiotherapy naïve
  • 5Planned to be initiated on first cycle of chemotherapy
  • 6Belongs to normal nutritional or under-nutritional status

排除标准

  • 1Overweight and obese children or adolescents
  • 2Children who are not planned to be initiated on chemotherapy
  • 3Intake of olanzapine for more than 5 days per month for non trial indication
  • 4Children taking antipsychotics or antidepressants for any psychiatric or non psychiatric indication
  • 5Prolonged use of systemic corticosteroids Prednisolone or prednisolone-equivalent of more than or equal to 5 mg for more than a week in the previous 28 days.
  • 6Children with intracranial neoplasms
  • 7Children with hematological malignancies
  • 8Children with intellectual disability
  • 9Children with concomitant chronic infections like osteomyelitis, tuberculosis, meningitis, suppurative infections, etc.
  • 10Inability to take oral medications

研究者

发起方
Prof Sameer Bakhshi PI

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