Evaluation of effectiveness of Fosaprepitant in PREVENTION of vomiting caused by cancer medicationIN children aged 1 to 12 years.

Phase 3

Conditions: Health Condition 1: R111- Vomiting

Registration Number: CTRI/2020/06/025872

Lead Sponsor: Hemato Oncology Clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients aged between 1 to 12 years

Patients with Histologically or cytological confirmed tumors

Patient naÃ¯ve to chemotherapy.

Scheduled to receive their first course of chemotherapy (HEC/MEC) for treatment of a solid malignant tumor.

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

Predicted life expectancy of at least 3 months

Willing to provide written informed consent by parent or guardian and oral assent by patient.

Exclusion Criteria

Radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5.

Bone marrow or stem-cell transplant.

Vomiting, retching, or more than mild nausea within 24 hours before day 1

Children with allergy to NK-1 antagonists or 5HT3 antagonists

Children with active infection

Children with congestive heart failure or known history of QT prolongation on electrocardiogram

Abnormal blood parameter (absolute neutrophil count < 1000/mm3, platelet count < 100 000/mm3)

Abnormal kidney function indicated by a serum creatinine more than the upper limit of normal (ULN) for age

Abnormal liver function test indicated by serum aspartate aminotransferase and alanine aminotransferase five times the ULN for age and serum bilirubin 1.5 times the ULN for age

Not willing to participate in the study or who have participated in any other clinical study in past 1 month.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of patients who achieved a complete response (defined as no vomiting, no use of rescue medication) during the 25â??120 hours (delayed phase). <br/ ><br>Timepoint: 1. no vomiting, no use of rescue medication) during the 25â??120 hours (delayed phase)

Secondary Outcome Measures

Name	Time	Method
1. Proportion of patients who achieved complete response during the acute (0â??24 hours) and overall phases. <br/ ><br>2. Any adverse effect seen or reported by patient/caretaker.Timepoint: 1. 0 - 24 hrs <br/ ><br>2. 6 days