A Clinical Trial to compare the effects of two drugs, Aprepitant and Fosaprepitant, in Children and Adolescents receiving Chemotherapy for Cancer

Phase 3

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2019/05/019082
• Lead Sponsor: Prof Sameer Bakhshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age between 5 years to <=18 years, with weight >=15kg

2. Patients with pathologically confirmed malignancies

3. Chemo-naïve

4. Scheduled to receive first cycle of HEC

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

6. ECOG PS 3 due to the underlying malignancy

7. Childrenâ??s caregiver(s) can understand Hindi or English, and are willing for participation in the study and for follow-up

Exclusion Criteria

1. Vomiting, retching, or more than mild nausea within 24 hours before the start of chemotherapy

2. Any history of CNS disease including brain metastasis, seizure disorder or psychosis

3. Significant organ dysfunction: SGOT/ SGPT >2.5x ULN, S. bilirubin >1.5x ULN, S. creatinine >1.5x ULN

4. Active infection or uncontrolled medical condition other than malignancy

5. Not willing to participate in the study

6. Need for contraindicated concomitant medication (pimozide, terfenadine, astemizole, or cisapride)

7. Need for medication that strongly induces CYP3A4 activity (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital)

8. Patients on systemic steroids other than for use as an antiemetic agent

9. Prior aprepitant/fosaprepitant use

10. Received radiotherapy to 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
Proportion of patients in IV fosaprepitant or oral aprepitant arms who achieve a complete response (defined as no vomiting, no retching, and no use of rescue medications) during the acute phase of the first cycle of Highly-Emetogenic chemotherapyTimepoint: Acute phase (from the initiation of chemotherapy till 24 hours after the completion of the last dose of chemotherapy)