Evaluation the Therapeutic and Molecular Effect of Carica Papaya aqueous Leaf Extract On Platelet Count in Chemotherapy -induced Thrombocytopenia in Ovarian Cancer Patients

Background:

Chemotherapy-induced thrombocytopenia (CIT) is one of the commonest side effects of cancer chemotherapy. A number of drugs have been tried, but all of them are associated with adverse effects. Studies show that Carica papaya leaf extracts (CPLE) over expresses arachidonate 12-lipoxygenase (ALOX-12) and platelet-activating factor receptor gene which stimulates the megakaryopoiesis.

Aims and Objectives: To evaluate the efficacy and safety of CPLE in CIT in cancer patients.

Materials and Methods:

Drug administration:

A total of  80 patients diagnosed to have CIT after cancer chemotherapy will be randomized into two groups of  40 subjects each. Interventional group will receive CPLE 1100 mg TID for 7 days post chemotherapy day 7-14 and the non-interventional group will be control group, without any intervention.

Complete hemogram will be done at post chemotherapy day7±4 and 16±4.

Patients will be followed up for 15 days for appearance of any adverse effects.

Statistical analysis will be done to achieve a conclusion.

Molecular Testing:

EDTA Blood collection, plasma isolation and qPCR analysis and in-silico studies will be done for arachidonate 12-lipoxygenase (ALOX 12) and platelet-activating factor receptor (PTAFR) genes. It will be done on 10 cases from the both arm, interventional and non-interventional group.

Expected outcome: Safety and efficacy of the drug will be observed, which will be validated by gene expression in plasma.