Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
DrNPKTeja Self
Eligibility
Inclusion criteria
Inclusion criteria: All patients who have histopathologically confirmed breast malignancy and Fit to receive Doxorubicin and Cyclophosphamide chemotherapy Chemotherapy naive Age above 18 years Participants with a.Haemoglobin above 8gm/dl, b.Platelet count above 1,00,000/mm3 c.Absolute neutrophil count above 1500/ mm3 Patients with Left Ventricular Ejection Fraction more than 50%. Participants with ECOG (Eastern Co-operative Oncology Group) performance status of 0-2.
Exclusion criteria
Exclusion criteria: Not willing to provide informed consent Participants with history of, use of drugs causing bone marrow toxicity like, Lamotrigine, Dapsone, Quinidine,Quinine, Propylthiouracil, Clozapine, Vancomycin in the past 2 months. Patients with Chronic Kidney Disease with Creatinine clearance lesser than 30ml/min Patients with Chronic hepatic disorders with Serum total Bilirubin greater than 5mg/dl and Transaminases (ALT & AST more than 5 times normal limit Patients with refractory anaemia and with history of blood transfusions Patients with Uncontrolled Diabetes Mellitus with HbA1c greater than or equal to 8% . Diabetic patients receiving Insulin. Patients who are on keto diet. Participants with history of alcohol intake in the past 7 days. Patients with known hypersensitivity to Doxorubicin or Cyclophosphamide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To find association between Serum Beta Hydroxy Butyrate levels and development of neutropenia after administration of Doxorubicin and Cyclophosphamide for breast cancerTimepoint: day 0, day 14 or before second cycle of chemotherapy, last day of chemotherapy of 4 to 6 cycles of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate a cutoff level of serum Beta hydroxy butyrate levels for development of neutropenia using a ROC (Receiver Operating Characteristic) Curve, in the presence of an association between them. Exploration of role of serum BHB levels in Doxorubicin and Cyclophosphamide chemotherapy induced cardiotoxicity.Timepoint: day 0, day 14 or before second cycle of chemotherapy, last day of chemotherapy of 4 to 6 cycles of chemotherapy. | — |
Countries
India
Contacts
Public ContactDr.N.P.K.Teja
AIIMS Rishikesh
Outcome results
None listed