Status:
COMPLETED
Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
Dr. Reddy's Laboratories Limited
Conditions:
Chemotherapy Induced Nausea and Vomiting
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
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 c...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01402024
Start Date
August 1 2011
End Date
June 1 2013
Last Update
January 19 2015
Active Locations (1)
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1
Dr. BRA IRCH, AIIMS
New Delhi, National Capital Territory of Delhi, India, 110029