Olanzapine for weight gain for children undergoing chemotherapy for solid malignancies: An Investigator-Initiated, Open-Label, Multi-Center, Phase III Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Proportion of children achieving weight gain more than or equal to 5 percentage at the end of 12 weeks of receipt of olanzapine plus standard dietary counselling versus standard dietary counselling alone among those undergoing chemotherapy for solid malignancies
研究概览
简要总结
Cancer cachexia has a profound impact on the survival of cancer patients and it is estimated that it is responsible for almost a quarter of deaths among cancer patients. Notably, poor nutritional status also affects chemotherapy tolerance and enhances the susceptibility to infections. Malnutrition also alters the body composition and thereby the pharmacokinetics of chemotherapeutic modalities. This culminates in delayed recovery of marrow functions and delay in treatment which has an unfavorable impact on the overall response to therapy. Hence there is an unmet need to develop or find agents for improving appetite and maintaining body composition among cancer patients to reverse this state of negative energy balance which would likely have an impact on clinically relevant outcomes like overall survival. As we are progressing towards a global improvement in pediatric cancer cure rates and survival, it is imperative that we deal with other factors which have key impact on the development and neuro-cognition of pediatric cancer survivors.
There is a serious dearth of academic publications and well conducted trials catering to the nutrition interventions for improving outcomes in pediatric oncology practice. This trial aims to address this unmet need and plans to explore olanzapine as a therapeutic modality in causing weight gain and improving appetite among pediatric patients with solid malignancies. Olanzapine is an easily available, safe and well-tolerated drug which has pleiotropic effects among cancer patients. It can be a useful addition to the therapeutic armamentarium for nutritional improvement among children with cancer. In this trial, we intend to demonstrate weight gain along with improvement in appetite, anorexia, anthropometric parameters and quality of life using olanzapine in children undergoing chemotherapy for solid malignancies. This shall be an open-label, investigator-initiated, multicenter, randomized phase 3 clinical trial with a proposed sample size of 140 patients. These shall be children with therapy naive solid malignancies in the age group of 2-18 years and will be randomized 1:1 into Arm A (Olanzapine tablet daily for 12 weeks + standard dietary counselling) or Arm B (Standard dietary counselling for 12 weeks). Primary outcome shall be to observe the proportion of children with weight gain of more than or equal to 5 percentage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Children and adolescents aged 2 to <18 years at the time of enrolment b) Body weight of atleast 10 kilograms c) Diagnosis of a solid malignancy d) Chemotherapy/ Radiotherapy naïve e) Planned to be initiated on first cycle of chemotherapy.
排除标准
- •1 Overweight and obese children or adolescents (For children aged 2 years and above to less than 5 years: obesity shall be defined as per World Health Organization (WHO) as a weight-for-height (WFH) Z-score greater than three; For children and adolescents aged 5 years and above up to 18 years, obesity shall be defined as per Indian Academy of Pediatrics (IAP) as a body-mass index (BMI) Z-score greater than 1.33 in boys and 1.63 in girls) 2 Children who are not planned to be initiated on chemotherapy 3 Intake of olanzapine for more than 5 days per month for non trial indication 4 Children taking antipsychotics or antidepressants for any psychiatric or non psychiatric indication 5 Prolonged 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.
- •6 Children with intracranial neoplasms 7 Children with hematological malignancies 8 Children with intellectual disability 9 Children with concomitant chronic infections like osteomyelitis, tuberculosis, meningitis, suppurative infections, etc.
- •10 Inability to take oral medications 11 Severe organ damage based on laboratory investigations within 2 weeks at the time of screening (hepatic- transaminitis more than or equal to 5 times upper limit normal or bilirubin more than or equal to three times upper limit of normal; renal- serum creatinine levels more than or equal to 1.5 times upper limit of normal; any evidence of heart failure) 12 Qtc interval prolongation: more than or equal to 450 msec by Fredericia formula 13 Raised serum amylase levels (more than upper limit normal).
结局指标
主要结局
Proportion of children achieving weight gain more than or equal to 5 percentage at the end of 12 weeks of receipt of olanzapine plus standard dietary counselling versus standard dietary counselling alone among those undergoing chemotherapy for solid malignancies
时间窗: 3 weeks 6 weeks 9 weeks and 12 weeks
次要结局
- Improvement in anorexia scores(3 weeks 6 weeks 9 weeks and 12 weeks)
- Change in quality of life(6 weeks and 12 weeks)
- Change in anthropometric parameters(3 weeks 6 weeks 9 weeks and 12 weeks)
- Event free survival and Overall survival(12 weeks)
- Improvement in caloric intake(3 weeks 6 weeks 9 weeks and 12 weeks)
- Adverse effect profile(3 weeks 6 weeks 12 weeks)
- Grade 3 or 4 chemotoxicity assessment(3 weeks 6 weeks 9 weeks and 12 weeks)
研究者
Sameer Bakhshi
All India Institute of Medical Sciences, New Delhi