Status:
UNKNOWN
A Study to Assess the Anti-Emetic Efficacy of Ginger in Children and Adolescents Receiving Chemotherapy
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
8-21 years
Phase:
PHASE3
Brief Summary
Ginger root powder is found to be significantly effective,when given as an add-on therapy in reducing chemotherapy induced nausea and vomiting in children and adolescents receiving chemotherapy. It i...
Detailed Description
Cisplatin is a chemotherapeutic agent with high emetogenic potential. High doses of Cisplatin (120 mg/m2) induces nausea and vomiting in 90 % of patients. More than 60% of patients experience nausea a...
Eligibility Criteria
Inclusion
- All patients must have a histologically confirmed diagnosis of Osteosarcoma/ Malignant Fibrohistiocytoma of bone that is currently being treated with chemotherapy with high emetogenic potential chemotherapeutic agent(Cisplatin at a dose 120mg/m2 ; Adriamycin 75 mg/m2)
- Age group : 8-21 yrs.
- Weight : greater than or equal to 20 kg and less than 40 kg in Category 1
- Weight : greater than or equal to 40 kg and less than 60 kg in Category 2
- Patients who are willing to participate in study.
- Patients or their parents who can understand Hindi or English.
Exclusion
- Patients of age \<8 yrs or age \>21 yrs.
- Weight \< 20 kg and greater than or equal to 40 kg in Category 1
- Weight \< 40 kg and greater than or equal to 60 kg in Category 2
- Patients receiving chemotherapy with drugs other than Cisplatin.
- Patients receiving a dosage of chemotherapy with Cisplatin\<120 mg/m2.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00940368
Start Date
June 1 2009
End Date
January 1 2010
Last Update
July 28 2009
Active Locations (1)
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1
Dr. B.R. Ambedkar Institute Rotary Cancer Hospital
New Delhi, National Capital Territory of Delhi, India, 110049