Clinical evaluation of effect of metronomic chemotherapy in cachexia associated with triple negative breast cancer.

NA6 个研究点分布在 1 个国家目标入组 254 人开始时间: 2025年6月6日最近更新: 2024年7月13日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 254
试验地点: 6
主要终点: Outcome No. 1- Body mass and body composition parameters

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is non-randomized, open label and parallel arm study comparing the safety and efficacy of metronomic chemotherapy over chemotherapy in patients suffering from cachexia associated with triple negative breast cancer in India. Patients will be recruited based on the inclusion and exclusion criteria and also dependent upon financial feasibility. Informed consent of the participants will be taken through ICF. Blood/ tissue samples of the patients suffering from TNBC will be collected. The primary outcome will measure parameters related to cachexia such as body mass and composition parameters, performance tests, inflammatory markers, markers of carbohydrate metabolism, markers of lipid metabolism, skeletal muscle wasting parameters. The secondary outcomes will be tumor progression, adverse events, quality of life and nutritional assessment questionnaire. Apart from this, allelic imbalance in small cohort samples will also be performed.

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 80.00 Year(s)（—）
性别: Female

入选标准

•Female patients with age more than equal to 18 years and less than equal to 80 years.
•Patients with confirmed TNBC from pathological reports, previously treated or not with other drugs for the metastatic disease.
•Patients with more than equal to 1 measurable lesion according to RECIST 1.1 criteria, ECOG score less than equal to 2 and life expectancy of more than equal to 16 weeks.
•Patients with adequate bone marrow, hepatic, and renal functions, indicated by haemoglobin more than equal to 10g per L, absolute neutrophil count more than equal to 1.5 billion neutrophils per liter of blood, platelet count more than equal to 100 billion platelets per liter of blood, total serum bilirubin less than 1.5 of upper normal limit (UNL), AST/ALT less than 2.5 of UNL, (less than 3.5 of UNL for liver metastases), or alkaline phosphatase less than 2.5 of UNL (less than 5 of UNL for bone/liver metastases).
•Evidence of cachexia as judged by one of: a.
•More than equal to 5 percent of documented weight loss in the previous 6 months.
•A subjective report of weight loss in the previous 6 months and a recorded BMI less than 20 kilograms per square meter.
•Ongoing documented weight loss of at least 1 kg in the week prior to day 0; or 1.25 kg in the 2 weeks prior to day 0, or 1.5 kg in the 3 to 6 weeks prior to day 0; provided that BMI is not more than 25 kilograms per square meter.

排除标准

•Patients not ready to provide written informed consent.
•Patient with other severe co-morbidities like renal or hepatic complications, cardiac disease, uncontrolled diabetes or hypercalcemia, severe peripheral neuropathy, active infection, or previous organ allograft.
•Patients with history of another malignancy.
•Patients unable to swallow pills or gastrointestinal conditions that might predispose to drug intolerability or poor drug absorption.
•Pregnant or lactating women.
•Patients with history of hypersensitivity to any of the regimen to be used in capecitabine, methotrexate and cyclophosphamide.
•Women who had participated in another clinical trial with any investigational drug within 30 days before study inclusion.