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

NCT01402024 | Completed Phase 3 DMC

• 1 other identifier: CT/38/011/RS
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy Induced Nausea and Vomiting

Outcome Measures

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.

  5 days

Secondary Outcomes (1)

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

  5 days

Study Arms (2)

Aprepitant

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Empov

Aprepitant

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).

Also known as: Empov placebo capsules

Control

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Dr. Reddy's Laboratories Limited: collaborator

Study Sites (1)

Dr. BRA IRCH, AIIMS

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

Location

MeSH Terms

Conditions

Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sameer Bakhshi, MD

  Dr. BRA IRCH, AIIMS, New Delhi (India)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 26, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

IN (1)