Role of serum Beta Hydroxy Butyrate levels in Doxorubicin and Cyclophosphamide induced neutropenia in breast cancer patients: A Pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To find association between Serum Beta Hydroxy Butyrate levels and development of neutropenia after administration of Doxorubicin and Cyclophosphamide for breast cancer
研究概览
简要总结
This is a prospective, observational, pilot study which aims to explore the role of Serum Beta hydroxy butyrate levels in predicting neutropenia in patients receiving Doxorubicin and Cyclophosphamide regimen in patients diagnosed with breast cancer.
Aim:
To explore the role of serum Beta hydroxy butyrate levels in prediction of Doxorubicin and Cyclophosphamide induced neutropenia in breast cancer patients.
Objectives:
Primary objective:
Ø A study of correlation between serum BHB levels and development of Doxorubicin and Cyclophosphamide induced neutropenia.
Secondary objective:
Ø Development of an algorithm or a scoring system, in the presence of a correlation between serum BHB levels and development of neutropenia.
Ø Exploration of role of serum BHB levels in other toxicities of Doxorubicin and Cyclophosphamide chemotherapy like cardiotoxicity and alopecia.
sample size- 30 participants.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To find association between Serum Beta Hydroxy Butyrate levels and development of neutropenia after administration of Doxorubicin and Cyclophosphamide for breast cancer
时间窗: day 0, day 14 or before second cycle of chemotherapy, last day of chemotherapy of 4 to 6 cycles of chemotherapy.
次要结局
- 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.)
研究者
Dr N.P.K.Teja
AIIMS Rishikesh