Chemotherapy induced nausea and vomiting (CINV) is one of the most distressing toxicities of cancer treatment. It can occur up to 90% in case of highly emetogenic chemotherapy (HEC) use. It is important to effectively manage CINV for a number of reasons. Acute phase vomiting can lead to vomiting in the delayed phase. It causes poor compliance with further therapy. Quality of life is compromised. It is easier to prevent nausea/vomiting than to treat it. Though strategies for prevention of CINV have been improved, it is still a significant problem. Newer drugs were explored and studied. The complete response rates were further increased with usage of olanzapine, an FDA approved antipsychotic, which blocks multiple neurotransmitters in the central nervous system. Olanzapine has been studied in multiple randomized trials in adults for its safety and efficacy in prevention of CINV. Various RCTs have demonstrated the superiority of olanzapine for prevention of CINV in patients receiving highly and moderately emetogenic chemotherapy. Olanzapine has been approved for prevention of CINV in adults. Unfortunately there are no large randomized trials demonstrating the efficacy of olanzapine for CINV prevention in children receiving HEC. The positive experience with olanzapine reported in adult oncology patients has prompted some pediatric clinicians to prescribe olanzapine for individual children receiving chemotherapy. Olanzapine is frequently used for the treatment of schizophrenia and bipolar disorder in children and adolescents. Though various studies have demonstrated safety of olanzapine in children, data regarding the efficacy of olanzapine in children and adolescents for prevention of CINV is limited. There are many small studies describing the safety and efficacy of olanzapine for prevention of CINV. However, there are no large randomized trials. Olanzapine is available in generic form and is not an expensive drug. Therefore we would like to conduct a randomized trial to look for the efficacy of olanzapine in pediatric population for prevention of CINV
Children and adolescents registered with confirmed diagnosis of cancer will be assessed for eligibility criteria and enrolled in the study. Subjects will be randomized into study and control groups using table of random numbers generated by computer. Sequentially numbered, opaque, sealed envelopes will be used for concealed allocation. After randomization, subjects will be interviewed 1 hour prior 1st dose of chemotherapy. Subjects will receive the antiemetic drugs for four days as per the allotted arm. All doses will be administered under supervision and 30 minutes before chemotherapy. The data will be collected from each patient from day 1 to day5 from the last dose of chemotherapy. The details will contain different items dealing with demographic and clinical characteristic of the subjects. A Diary will be maintained for nausea and vomiting episodes. It will help in collecting data regarding nausea, vomiting along with some additional variables like chemotherapy related toxicities, requirement of any rescue medication. The subjects will be given the diary for symptom assessment on day 1 and it will be filled up under the supervision of the investigator on day 1 till completion of chemotherapy. The diary will be given to the subjects following the completion of chemotherapy to record all the events (incidence and severity of nausea, vomiting, requirement of rescue medication and other toxicities ) and will be contacted by phone or in person by the investigator. Edmonton's symptom assessment criterion will be used in the diary for assessing severity of nausea. The NCI's CTCAEv4.03 criterion will be used to assess the severity of vomiting and adverse events based on the data provided by the patient in the diary. Patients/attendants will be explained about the filling of the diary and will maintain it for recording of vomiting. A modified intention-to-treat population will be used for efficacy analysis. Proportion of patients with CR during acute phase, delayed phase and overall period will be compared between the two arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
240
Ondansetron will be given at a dosage of 0.15mg/kg IV/PO q8h.
Dexamethasone will be given as 3mg/m2 IV/PO q8h.
Aprepitant will be given as per the weight. weight (15-40kg) - Day1 to Day 3 - 80 mg PO weight (\>40 kg) - Day 1 -125mg , Day 2 \& Day 3 - 80 mg PO
olanzapine will be given as 0.14mg/kg PO (rounded off to nearest 2.5 mg )
Dr Bra Irch, Aiims, New Delhi
New Delhi, National Capital Territory of Delhi, India
The number of patients with no episodes of vomiting as assessed by CTCAE v4.03 till 120 hours after highly emetogenic chemotherapy.
The number of patients achieving complete response as defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
Time frame: 120 hours after administration of chemotherapy.
The number of patients with no episodes of vomiting as assessed by CTCAE v.03 till 24 hours after highly emetogenic chemotherapy.
The number of patients achieving complete response: defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
Time frame: Till 24 hours after administration of chemotherapy.
The number of patients with no episodes of vomiting as assessed by CTCAE v4.03after 24 hours till 120 hours post highly emetogenic chemotherapy.
The number of patients achieving complete response as defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
Time frame: From 24 hours till 120 hours post administration of chemotherapy.
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" till 24 hours after highly emetogenic chemotherapy.
The no.of patients with no nausea, assessed by "Edmonton symptom assessment scale" during the study period will be compared between the groups
Time frame: Till 24 hours after administration of chemotherapy.
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" after 24 hours till 120 hours post highly emetogenic chemotherapy.
The no.of patients with no nausea, assessed by "Edmonton symptom assessment scale" during the study period will be compared between the groups
Time frame: After 24 hours till 120 hours post administration of chemotherapy.
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" till 120 hours post highly emetogenic chemotherapy.
The no.of patients with no nausea, assessed by "Edmonton symptom assessment scale" during the study period will be compared between the groups
Time frame: Till 120 hours after administration of chemotherapy.
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