Aprepitant for chemotherapy induced vomiting and nausea during acute myeloid leukemia chemotherapy among children and adolescents

Phase 3

• Conditions: Health Condition 1: C920- Acute myeloblastic leukemia

• Registration Number: CTRI/2023/06/054320
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients with no episodes of vomiting as assessed by CTCAE <br/ ><br>V5.01 and no use of rescue medication during delayed periodTimepoint: The number of patients with no episodes of vomiting as assessed by CTCAE <br/ ><br>V5.01 and no use of rescue medication during delayed period ie 24 to 120 hours post chemotherapy

Secondary Outcome Measures

Name	Time	Method
1. The number of patients with no episodes of vomiting as assessed by CTCAE <br/ ><br>v4.03 and no use of rescue medication during acute and overall period <br/ ><br>2. The number of patients with no episodes of nausea as assessed by ESAS scale at acute /delayed/overall phases across all study centres <br/ ><br>3. The number of patients with no episodes of nausea as assessed by PeNAT scale at acute /delayed/overall phases across Hindi speaking centres <br/ ><br>4. The number of patients with breakthrough emesis and nausea in acute, delayed, and overall phases. <br/ ><br>5. The number of patients in whom rescue antiemetics used in acute, delayed, and overall phases <br/ ><br>6. Incidences of adverse effects of antiemetics across study groups. <br/ ><br>Timepoint: Acute period - 0 to 24 hours after chemotherapy <br/ ><br>Delayed period -24-120 hours post chemotherapy <br/ ><br>Overall period- 0-120 hours post chemotherapy