| Protocol No: | ECCT/24/02/05 | Date of Protocol: | 21-12-2021 |
| Study Title: | Pharmacokinetic profiles for Doxorubicin among children with childhood cancer in Kenya.
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| Study Objectives: |
Primary Objective:
To evaluate the PK profiles of Doxorubicin in children with cancer in Lilongwe-Malawi and Eldoret-Kenya.
Secondary objectives:
1. To evaluate the PK profiles of Doxorubicin and Doxorubicinol in relation to age
2. To evaluate the PK profiles of Doxorubicin and Doxorubicinol in relation to nutritional status
3. To evaluate the PK profiles of Doxorubicin and Doxorubicinol in relation to genetic
polymorphisms
4. To evaluate the PK profiles of Doxorubicin and Doxorubicinol in relation to racial background.
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| Laymans Summary: | ABSTRACT
Background: Cancer is a leading cause of death among children worldwide. Doxorubicin has been an effective backbone for several childhood cancer treatment protocols; however, cardio toxicity often limits the clinical use. Pharmacokinetics (PK) are extremely important in predicting safe and effective chemotherapy but data for Doxorubicin with regard to nutritional status and genetic polymorphisms associated with drug metabolism among different ethnicities is largely lacking.
Relevance of the study: More knowledge about the PK of Doxorubicin among children with varying ages, different nutritional profiles, as well as different ethnicities, in the view of possible genetic polymorphisms is extremely important to improve short- and long-term outcomes. Better understanding of these variables could lead to a reduction in treatment-related toxicity and a more effective treatment for children with cancer worldwide.
Aim: We aim to evaluate the PK of Doxorubicin in children with cancer receiving Doxorubicin-based regimens in Eldoret-Kenya. The data generated will be used to determine a more appropriate Doxorubicin dosing regimen in different patient populations with respect to age, nutritional status and ethnicity. Based on a pharmacological rationale we hypothesize that PK-profiles for Doxorubicin in children with different ages, nutritional profiles and ethnicities will significantly differ.
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| Abstract of Study: | ABSTRACT
Background: Cancer is a leading cause of death among children worldwide. Doxorubicin has been an effective backbone for several childhood cancer treatment protocols; however, cardio toxicity often limits the clinical use. Pharmacokinetics (PK) are extremely important in predicting safe and effective chemotherapy but data for Doxorubicin with regard to nutritional status and genetic polymorphisms associated with drug metabolism among different ethnicities is largely lacking.
Relevance of the study: More knowledge about the PK of Doxorubicin among children with varying ages, different nutritional profiles, as well as different ethnicities, in the view of possible genetic polymorphisms is extremely important to improve short- and long-term outcomes. Better understanding of these variables could lead to a reduction in treatment-related toxicity and a more effective treatment for children with cancer worldwide.
Aim: We aim to evaluate the PK of Doxorubicin in children with cancer receiving Doxorubicin-based regimens in Eldoret-Kenya. The data generated will be used to determine a more appropriate Doxorubicin dosing regimen in different patient populations with respect to age, nutritional status and ethnicity. Based on a pharmacological rationale we hypothesize that PK-profiles for Doxorubicin in children with different ages, nutritional profiles and ethnicities will significantly differ.
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