Comparison of Dexamethasone sparing regimens with NEPA (Neupitant/Palonosetron) versus Dexamethasone containing antiemetic therapy for prevention of chemotherapy induced nausea and vomiting in Breast Cancer patients receiving Anthracycline and Cyclophosphamide chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Rating of nausea and vomiting will be by using MAT tool and CTCAE version 5.0
研究概览
简要总结
After obtaining IEC clearance and CTRI registration, eligible criteria patients will be included in this study. A structured data collection proforma will be used to enter the patient details, such as age, gender, comorbidities, and physical examination. Since it is the department standard protocol for chemotherapy-induced nausea and vomiting (CINV), we are observing the efficacy of two different treatments for CINV. Patients will be assigned to a dexamethasone-containing and dexamethasone-sparing anti-emetic regimen according to physician discretion.Patients receiving a dexamethasone-sparing regimen will be given dexamethasone only on the day of chemotherapy, along with NEPA on the same day, while patients receiving a dexamethasone-containing regimen will be given dexamethasone from days 1 to 4.The data regarding CINV will be collected on the next visit of the patient to the hospital.Patients are allowed to take rescue medication throughout the study period for nausea or vomiting, if necessary. The choice of recommended rescue medicine will be made from metoclopramide, domperidone, and gabapentin, and the same will be informed at the next visit.The period of assessment for CINV will be done within the first 24 hours after the administration of chemotherapy (acute chemotherapy-induced emesis) and after the initial 24-h period from the 2nd to the 5th day after chemotherapy (delayed emesis).Response Rate will be defined as: Overall complete response (CR-O), defined as no vomiting and no need for rescue medication, at cycle 1 (Time frame: 0–120 h) Complete response during acute phase (CR-AP), defined as no vomiting and no need for rescue medication, at cycle 1 (Time frame: 0–24 h) and Complete response during delayed phase (CR-DP), defined as no vomiting and no need for rescue medication, at cycle 1 (Time frame: 24–120 h). Overall complete protection (CP-O), defined as no significant (< 2.5 mm on VAS) nausea, no and no use of rescue medication (time frame: 0–120 h). No nausea: complete absence of nausea (VAS score 0).Rescue medication is defined as any medication taken in addition to prophylactic treatment for control of nausea or vomiting. In case of any vomiting or nausea, patients will be asked to call the principal investigator by phone, and the rescue medication will be prescribed by the principal investigator.CINV will be assessed by:MAT tool (MASCC Assessment Tool) questionnaire:The translation process highlighted by the MASCC guidelines was followed, and Kannada translation was done by a bilingual translator and was verified by a second translator independently. CTCAE (define the grades 1-4)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients diagnosed with breast cancer and receiving Anthracycline and cyclophosphamide-based highly emetogenic chemotherapy Adequate Organ function -serum creatinine less than 2.0 mg/dL; serum bilirubin less than 2.0 mg/dL; serum glutamic-oxaloacetic transaminase or serum glutamic-pyruvic transaminase less than or equal to three or more times the upper limits of normal; absolute neutrophil count greater than 1,500 mm3b).
排除标准
- •Patients with nausea in the 24 hours before beginning chemotherapy; Concurrent radiation therapy; Patients suffering from tumors with brain metastasis/ or with serious psychiatric conditions; Acutely ill patients such with serious liver and renal disorders and serious cardiac disorders with left ventricular ejection fraction less than 50%; Pregnant and lactating women; Unable or refused to cooperate in the evaluation form of nausea and vomiting.
结局指标
主要结局
Rating of nausea and vomiting will be by using MAT tool and CTCAE version 5.0
时间窗: At baseline and 2 weeks
The proportion of patients achieving Overall complete response, Complete response during acute phase, Complete response during delayed phase, Overall complete protection, and No nausea
时间窗: At baseline and 2 weeks
次要结局
- not applicable(not applicable)
研究者
Dr Tarun Tomar
Kasturba Medical College and Hospital
