Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy
Condition: Chemotherapy Induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Population:

      Children and adolescents (5-18 years) with weight between 15-65 kg receiving highly
      emetogenic chemotherapy (HEC) -

        -  VAC (vincristine, dactinomycin/Adriamycin, cyclophosphamide)

        -  ABVD (adriamycin, bleomycin, vinblastine, dacarbazine)

        -  Cisplatin/Doxorubicin

      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:

        1. The data will be collected from each patient from d1 to d10 of chemotherapy of which
           patient will received chemotherapy in day care, maximum up to d3.

        2. After taking consent patient will be enrolled as per inclusion and exclusion criteria,
           and randomized to one of two groups. All baseline assessment will be done. Patient will
           be explained about the filling of the diary. In first 2 days. The subjects will fill the
           diary under the investigator supervision, and the rest of filling will be in home.
           Reinforcement will be done over phone.

      Procedure of double blinding

        -  Double blinding will be done for the intervention. Four different boxes will be made for
           capsules. Total 3 capsules for 3 days will be made in a blister pack, mentioning the d1,
           d2, d3 (for each capsule). Two different body weight groups will be made: 15-40 kg, and
           41-65 kg.

        -  Group "A" will be the code for Aprepitant group and group "B" will be code for control
           group. Both patient and the investigator will be blinded regarding medicine in the code.
    

Intervention name(s): Aprepitant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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).
Other intervention name(s): Empov; Empov placebo capsules
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention