A Phase 3 interventional study of Aprepitant and Placebo in Chemotherapy Induced Nausea and Vomiting, sponsored by All India Institute of Medical Sciences, New Delhi. Completed at 1 site in India. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by All India Institute of Medical Sciences, New Delhi · Phase 3, Interventional, and Prevention
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.
Population:
Children and adolescents (5-18 years) with weight between 15-65 kg receiving highly emetogenic chemotherapy (HEC) -
Sampling technique Subjects who met the eligibility criteria will be randomly assigned using random allocation number generated by computer into one of the two groups. The unit of randomization will be the subject at first cycle of HEC. The same patient will not be enrolled for twice
Procedure for data collection:
Procedure of double blinding
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's enrollment of 96 is below the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
It is an double blind randomized placebo controlled trial with age group of 5-18 years and weight between 15-65 kg, who will receive highly emetogenic chemotherapy. Patient who will meet the inclusion criteria will be randomly enrolled in either of the two arm-aprepitant arm and control arm. The patient on aprepitant arm will receive the study drug (aprepitant)along with standard anti-emetic therapy (as per the dosages mentioned in the protocol).
Drug: Aprepitant
It is an double blind randomized placebo controlled trial with age group of 5-18 years and weight between 15-65 kg, who will receive highly emetogenic chemotherapy. Patient who will meet the inclusion criteria will be randomly enrolled in either of the two arm-aprepitant arm and control arm. The patient on the control arm will receive the placebo along with standard anti-emetic therapy (as per the dosages mentioned in the protocol).
Drug: Placebo
The patient on study group with weight category of 15-40 kg will receive: D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg and The patient with weight category of 41-65 kg in study group will receive: D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 125 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg
Also known as: Empov
Patient on control group with weight category of 15-40 kg will receive: D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; and The patient on control group with weight category of 41-65 kg will receive: D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 125 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg (all are injectable except Aprepitant oral capsule).
Also known as: Empov placebo capsules
- Numbers of episodes of nausea and vomiting. - Duration of nausea (in hours). - Severity of nausea as per Edmonton's Symptom Assessment System (ESAS), numerical scale for nausea.
Time frame: 5 days
- Chemotherapy induced additional side effects. - Number of anti-emetic dosage (other than aprepitant) required for treatment of vomiting.
Time frame: 5 days
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, New Delhi