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NCT Number: NCT01402024

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

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.

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Key information

Conditions

Chemotherapy Induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. BRA IRCH, AIIMS

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant

Drug

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

Other names: Empov

Placebo

Drug

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 names: Empov placebo capsules

Primary outcomes

  1. - 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

Secondary outcomes

  1. - Chemotherapy induced additional side effects. - Number of anti-emetic dosage (other than aprepitant) required for treatment of vomiting.

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Collaborators

  • Dr. Reddy's Laboratories Limited

Registry information

Official study title

A Study to Evaluate the Anti-emetic Effect of Aprepitant Versus Placebo as an Add-on Therapy in Children and Adolescent Receiving Chemotherapy: A Randomized, Doubly Blinded Controlled Trial

Acronym: Aprepitant

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2011
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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