Chemotherapy-induced Nausea and Vomiting Clinical Trial
— PRaCTiCEOfficial title:
"Olanzapine for Prevention of Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy (HEC): An Investigator Initiated, Randomized, Open-label Trial" (PRaCTiCE Trial: PRevention of ChemoTherapy Induced Emesis in Children)
Verified date | August 2019 |
Source | All India Institute of Medical Sciences, New Delhi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 240 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Age group 5-18 years with weight between =15 kg - All subjects must have a confirmed diagnosis of malignancy - European Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 - Scheduled to receive highly emetogenic chemotherapy as assessed using the Pediatric Oncology Group of Ontario Guideline for emetogenicity Classification - Patients receiving first cycle of chemotherapy - Children's caregiver who can understand Hindi or English and are willing to participate in the study (with written informed consent) Exclusion Criteria: - Have had treatment within 14 days prior to study enrollment with olanzapine or 30 days prior to study enrollment with another antipsychotic agent - Planned to receive quinolone antibiotics while receiving olanzapine - Have uncontrolled hypertension - Receive other antipsychotic agents, amifostine, citalopram, CYP1A2 inducers or inhibitors - Have a history of neuroleptic malignant syndrome, a seizure disorder, hypersensitivity to olanzapine. - Children with known cardiac disease - Are pregnant or breast-feeding - Had received or will receive RT to abdomen or pelvis in the week prior to treatment - Vomited in the 24 hours prior to study - Previous exposure to HEC - Abnormal 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, patient on systemic steroids |
Country | Name | City | State |
---|---|---|---|
India | Dr Bra Irch, Aiims, New Delhi | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 120 hours after administration of chemotherapy. | |
Primary | 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. | Till 24 hours after administration of chemotherapy. | |
Primary | 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. | From 24 hours till 120 hours post administration of chemotherapy. | |
Secondary | 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 | Till 24 hours after administration of chemotherapy. | |
Secondary | 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 | After 24 hours till 120 hours post administration of chemotherapy. | |
Secondary | 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 | Till 120 hours after administration of chemotherapy. |
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