Health Condition 1: null- Pediatric patients aged 2-14 years with varying nutritional status and diagnosed with various cancers and on standard regimens.
Conditions
Interventions
None listed
Sponsors
TRAC TMC Research Administration Council
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 2-14 years and diagnosed with cancer 2. Children receiving chemotherapy as per standard regimens at Tata Memorial Hospital. 3. Children who are receiving any of the following chemotherapeutic agents as part of standard therapy; -Vincristine -Etoposide -Doxorubicin -Cyclophosphamide/Ifosfamide -Actinomycin D 4. Children who have a reliable venous access (central/peripheral line)
Exclusion criteria
Exclusion criteria: 1. Children on concomitant Azole group of antifungal drugs 2. Children on chronic anticonvulsant therapy and long term steroid use 3. Parents refusing informed consent 4. Children taking chemotherapy at other centres.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the pharmacokinetics of common anticancer drugs in two sub-populations of children with cancer namely-undernourished and well-nourished. 2. To develop an algorithm/ dosing recommendationfor anticancer drugs in pediatric oncology patients with malnutritionTimepoint: Pharmacokinetic sampling for the drug will be done during cycle 1. A baseline sample for metabolomics study will also be collected. All patients will undergo routine intervention by the dieticians as per departmental policy. A repeat assay for drug pharmacokinetics and metabolomics assay will be done again during the 4th cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To define the relation between drug exposure and toxicity. 2. To determine the association between nutritional status and chemotherapy toxicity and survival outcomes (Event free and overall survival) 3. To understand the metabolic markers impacting drug disposition in children with cancer with varying nutritional states using a targeted metabolomics approach.Timepoint: Pharmacokinetic sampling for the drug will be done during cycle 1. A baseline sample for metabolomics study will also be collected. All patients will undergo routine intervention by the dieticians as per departmental policy. A repeat assay for drug pharmacokinetics and metabolomics assay will be done again during the 4th cycle. A 3mL blood sample will be taken for metabolomic analysis at baseline and in the middle of chemotherapy cycles. | — |
Countries
India
Contacts
Public ContactGirish Chinnaswamy
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed