Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system
Conditions
Interventions
Intervention1: Carica Papaya plus supportive care: Arm A
CPLE tablet
Route of administration: Oral
Dose Tablet CPLE PO 1100mg
Frequency three times as day
till recovery of Platelet counts more tha
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients with metastatic solid tumor malignancies receiving chemotherapy with the following preconditions Platelet counts and clinical parameters as follows -No active bleeding from any site or previous history of CIT and related bleeding -ECOG PS 0-2 -Platelet counts in the range - 75,000 and 25,000 -Hemoglobin levels more than or equal to 8 -Total leucocyte counts more than or equal to 2000 WBC per microliter and Absolute neutrophil counts more than or equal to 1000 neutrophils per microliter -No clinical or radiological evidence of infection/sepsis -Not having received growth factors in the last three weeks or not being planned for G-CSF/peg GCSF; not planned for blood or blood product transfusions - Received at least 2 prior cycles of the current chemotherapeutic regimen, i.e. only patients from cycle 3 of their current regimen will be considered for inclusion in trial -Patients who can give informed consent for the study. -Adequate organ function Liver functions- bilirubin less than or equal to 2 x upper limit normal (ULN), AST ALT ALP Adequate Renal function -Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial
Exclusion criteria
Exclusion criteria: Serious co-morbidities such as, but not limited to severe cardiac failure severe pulmonary compromise or severe and active infections. -Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. -Patients on other investigational drugs within the last 30 days. - Patients with inability to swallow oral medications -The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may impair swallowing or capability of oral intake of tablets - Platelet counts less than or equal to25,000 -Patients with documented Grade 2 or grade 3 thrombocytopenia on chemotherapy, but having concurrent newly diagnosed vitamin B12 or folate deficiency that requires supplementation -Patients with documented Grade 2 or grade 3 thrombocytopenia on chemotherapy, but having concurrent newly diagnosed iron deficiency anemia satisfying all the following criteria -Hemoglobin less than or equal to 10 -Se ferritin less than 21.8 ng/ml (males) and less than 4.6 ng/ml (females) -Transferrin saturation less than 15% If not satisfying the above criteria, patients can still be considered for study. - Presence of bleeding diathesis -Patients receiving Amiodarone currently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistically significantly faster and clinically relevant improvement in CIT (Grade 2 and Grade 3) to atleast more than or equal to 75,000 per mm3 with CPLE as compared to spontaneous recovery of CIT (placebo) within or at 7 days of starting CPLE.Timepoint: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -To evaluate safety profile of CPLE in patients receiving chemotherapy -To evaluate whether CPLE improves Grade 2 and grade 3 -To evaluate whether CPLE given for improves decreased platelet counts -To evaluate whether CPLE reduces platelet transfusion requirements in chemotherapy induced thrombocytopeniaTimepoint: 30 months | — |
Countries
India
Contacts
Public Contactvikas ostwal
Tata Memorial Hospital
Outcome results
None listed