â??Utility of olanzapine for prevention of nausea and vomiting in children and young adults receiving cancer chemotherapy.
- Conditions
- Health Condition 1: null- Children and adolescents (5-18 years) with weight between 15-65 kg receiving HEC at Dr. BRA IRCH, AIIMS and are able to swallow the study medication. Health Condition 2: C419- Malignant neoplasm of bone and articular cartilage, unspecified
- Registration Number
- CTRI/2017/07/009092
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
1. Children and adolescents of age group 5-18 years with weight 15kg or above,
2. All subjects must have a confirmed diagnosis of malignancy
3. European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
4. Scheduled to receive highly emetogenic chemotherapy as assessed using the Pediatric Oncology Group of Ontario Guideline for emetogenicity Classification
5. Patients receiving first cycle of chemotherapy
6. Childrenâ??s caregiver who can understand Hindi or English and are willing to participate in the study (with written informed consent)
a)Children who were treatment within 14 days prior to study enrollment with olanzapine or 30 days prior to study enrollment with another antipsychotic agent
b)Children who are planned to receive quinolone antibiotics while receiving olanzapine
c)Children with uncontrolled hypertension
d)Children who are receiving other antiphychotic agents, amifostine, citalopram, CYP1A2 inducers or inhibitors
e)Children with history of neuroleptic malignant syndrome, a seizure disorder, hypersensitivity to olanzapine.
f)Children with known cardiac disease
g)Pregnant or breast-feeding adolescents
h)Children who have received or will receive RT to abdomen or pelvis in the week prior to treatment
i)Children who had vomited in the 24 hours prior to study
k)Children with bnormal lab values (ANC <1500/mm3, TLC <3000/mm3, Plt <100,000/mm3, AST/ALT > 2.5 times of ULN, bill >1.5 times of ULN, S.cr >1.5 times of ULN
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare between the 2 arms, the number of patients with complete response (No emesis and use of rescue therapy) during the acute phase (0-24 hours post chemotherapy, delayed phase (25-120 hours from the last dose of chemotherapy) and overall period, post highly emetogenic chemotherapy(HEC) in children and adolescents <br/ ><br>Timepoint: Acute phase (0-24 hours post chemotherapy) <br/ ><br>Delayed phase (25-120 hours from the last dose of chemotherapy) <br/ ><br>Overall period (0-120 hours post chemotherapy) <br/ ><br>
- Secondary Outcome Measures
Name Time Method To compare between the control and study arms the proportion of patients with no nausea during the acute phase (0-24 hours post chemotherapy), delayed period (25-120 hours from the last dose of chemotherapy) and overall period (acute plus delayed) post highly emetogenic chemotherapy (HEC) in children and adolescentsTimepoint: Acute phase (0-24 hours post chemotherapy) <br/ ><br>Delayed phase (25-120 hours from the last dose of chemotherapy) <br/ ><br>Overall period (0-120 hours post chemotherapy) <br/ ><br>