Health Condition 1: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: Extended dose aprepitant during AML induction chemotherapy.
Aprepitant( NK1 receptor antagonist) oral tablets
125 mg once a day on day 1 ,80 mg once a day on days 2 ,day 3 of chemothera
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients with confirmed diagnosis of acute myeloid leukaemia Age more than or equal to 18 years, with weight more than or equal to 30 kg Chemo-naïve Scheduled to receive first cycle of AML induction chemotherapy 3 days of daunorubicin at 60 mg/m2 and 7 days of cytosine arabinoside infusion @ 100 mg/m2 24-hour infusion. Patient or their attendants can understand Hindi /Tamil/English, and are willing for participation 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 or SGPT more than 2.5 times ULN, S. bilirubin more than 1.5 times ULN, S. creatinine more than 1.5times 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 systemic steroids other than for use as an antiemetic agent Prior aprepitant or fosaprepitant use. Received radiotherapy to 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 period 24- 120 hours after AML induction chemotherapy Timepoint: Delayed period of chemotherapy induced nausea vomiting i.e 24- 120 hours after AML induction chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the proportion of patients in extended dose aprepitant or standard dose aprepitant arms who achieve a complete response during the acute phase and overall phase of first cycle of 3 days of daunorubicin and 7 days of cytosine arabinoside chemotherapy. To estimate number of breakthroughs vomiting episodes during acute chronic and overall phases and proportion of patients requiring rescue anti emetics To estimate the incidence and severity of nausea during acute, chronic, and overall phases in each arm. â?¢ To ascertain the incidence of side effects in each arm Timepoint: Acute phase 0-24 hours post chemotherapy Delayed phase 24-120 hours post chemotherapy Overall phase 0-120 hours post chemotherapy | — |
Countries
India
Contacts
Public ContactSanthosh Kumar K N
AIIMS, New Delhi
Outcome results
None listed