Health Condition 1: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: Extended dose aprepitant: Capsule Aprepitant per oral 125 mg on day 1 ,80 mg on day 2 and 3 with Capsule Aprepitant per oral 125 mg on day 6 and 80 mg on day 7 and 8 along with injec
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a confirmed diagnosis of acute myeloid leukemia Aged 5 to 18 years, with a weight of more than 15 kg. Chemo-naïve Scheduled to receive the first cycle of AML induction chemotherapy Patient or their attendants can understand Hindi or Tamil/English and are willing to participate in the study and for follow-up
Exclusion criteria
Exclusion criteria: Vomiting, retching, or more than mild nausea within 24 hours before the start of chemotherapy Any history of CNS disease including brain metastasis, seizure disorder, or psychosis Significant organ dysfunction: SGOT/ SGPT >2.5x ULN, S. bilirubin >1.5x ULN, S. creatinine >1.5x ULN Not willing to participate in the study. Need for contraindicated concomitant medication (pimozide, terfenadine, astemizole, or cisapride) Need for medication that strongly induces CYP3A4 activity (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital) Patients on steroids for systemic illness Prior aprepitant/ fosaprepitant use. Received radiotherapy to the abdomen, pelvis, cranium, or craniospinal regions, in the week prior to treatment initiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with no episodes of vomiting as assessed by CTCAE V5.01 and no use of rescue medication during delayed periodTimepoint: The number of patients with no episodes of vomiting as assessed by CTCAE V5.01 and no use of rescue medication during delayed period ie 24 to 120 hours post chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of patients with no episodes of vomiting as assessed by CTCAE v4.03 and no use of rescue medication during acute and overall period 2. The number of patients with no episodes of nausea as assessed by ESAS scale at acute /delayed/overall phases across all study centres 3. The number of patients with no episodes of nausea as assessed by PeNAT scale at acute /delayed/overall phases across Hindi speaking centres 4. The number of patients with breakthrough emesis and nausea in acute, delayed, and overall phases. 5. The number of patients in whom rescue antiemetics used in acute, delayed, and overall phases 6. Incidences of adverse effects of antiemetics across study groups. Timepoint: Acute period - 0 to 24 hours after chemotherapy Delayed period -24-120 hours post chemotherapy Overall period- 0-120 hours post chemotherapy | — |
Countries
India
Contacts
Public ContactDr Santhosh Kumar K N
AIIMS, New Delhi
Outcome results
None listed