Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Chemotherapy induced nausea and vomiting (CINV) is one of the few mostly observed distressing toxicity of cancer treatment. It can occur up to 90% in case of highly emetogenic chemotherapy use. CINV causes disturbance in daily living of cancer patient and reduces compliance with treatment Even with the standard anti-emetic measures up to 50% patient can suffer from this complication. Whereas there is standard anti-emetic guideline exists in case of adult patients, there no such guidelines made in pediatric population. The new drug Aprepitant has been recommended for use in adults with high efficacy, there no such concrete data available in children regarding its use. There are few retrospective reports and limited data available regarding use of Aprepitant in children with satisfactory efficacy in reducing CINV. As there no randomized large data to suggests its efficacy and its routine use in children, we have planned this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborator: Dr. Reddy's Laboratories Limited
• Treatments: Antiemetics; Aprepitant; Emetics; Fosaprepitant

Criteria

Inclusion Criteria:

• All subjects must have a confirmed diagnosis of malignancy and receiving highly emetogenic chemotherapy first time (VAC, ABVD and CDDP/Doxorubicin)

• Age group 5-18 years with weight between 15-65 kg

• Children/adolescents and their caregiver who can understand Hindi or English and willing to participate in the study (with written informed consent)

Exclusion Criteria:

• Significant organ dysfunction

• Active infection

• Pregnancy

• Uncontrolled medical condition other than malignancy

• Need for contraindicated concomitant medication

• Patients receiving chemotherapy other than VAC, ABVD and CDDP/Doxorubicin

• Treatment with another investigational drug within 4 weeks of study start or prior Aprepitant use

• Had received or will receive RT to abdomen or pelvis in the week prior to treatment

• Vomited in the 24 hr prior to treatment

• Prior exposure to highly emetogenic chemotherapeutics

• Abnormal lab values (ANC<1500/mm3, TLC<3000/mm3, Plt<100,000/mm3, AST/ALT> 2.5 times of ULN, bill>1.5 times of ULN, S.cr>1.5 times of ULN, patient on systemic steroids