Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This study evaluate the association of body composition (mainly free-fat mass), clinical and biochemical parameters with development of toxicity in patients under treatment with Carboplatin/Paclitaxel in advanced NSCLC.
详细描述
BACKGROUND
Lung cancer (LC) is the leading cause of cancer deaths worldwide, are attributed about 13% of all new cases of cancer and accounts for 19.4% of deaths from malignancies. In Mexico, this cancer is also the leading cause of death in malignant neoplasias. One of the reasons attributable the high mortality from this disease is that most cases are detected in advanced stages and this depends prognosis and treatment. Within the classification of LC the most prevalent is the Non Small Cell Lung Cancer (NSCLC); for which the considered first-line standard treatment is palliative cytotoxic chemotherapy, as the combination of carboplatin with paclitaxel and in the other hand one of the most recent combinations Carboplatin with Pemetrexed.
Malnutrition may affect 80% of patients with advanced cancer and is associated with up to 20% of deaths, with an increased risk in the development of complications and mortality and can extend the hospital stay up to 90%, increasing the cost of treatment in a 35-75%. Similarly, in a previous study at INCan, the degree of malnutrition in patients with LC was associated with cytotoxic chemotherapy toxicity and poorer prognosis and poorer quality of life. Sarcopenia is also a phenomenon commonly observed in patients with LC, there has been a prevalence of 61% and 31% in men and women respectively.
Carboplatin dose that is administered to the patient is calculated by the Calvert formula, this requires the calculation of glomerular filtration rate (GFR). There are various quantified and estimated methods to calculate GFR; however the validated and most commonly used is estimated by the Cockroft-Gault formulae. It is known that due to various factors, variables required for calculation (as creatinine) could be modify the result, may became unreliable, it is why it is important to consider changes in body composition of NSCLC patients with sarcopenia.
HYPOTHESIS:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NSCLC Stage IV (stratification according to the American Joint Committee on Cancers - 7th edition)
- •Candidates for treatment with carboplatin plus paclitaxel 1st line
- •Performance status (ECOG 0-2)
- •Laboratory studies that demonstrate adequate renal, hepatic and hematologic function (blood chemistry and blood count)
- •Normal renal ultrasound prior to initiation of treatment
排除标准
- •Patients with renal impairment (KDOQI 3-5)
- •Patients who do not have computed tomography study at baseline
- •Uncontrolled blood pressure (> 140 mmHg)
- •Uncontrolled diabetes (> 130 mg / dL)
- •Obstruction in kidney (s) or ureter (s)
- •Dehydrated patients
- •Patients with high consumption of NSAIDs (aspirin, ibuprofen, etc.> 1 month)
研究组 & 干预措施
Sarcopenic
Patients with sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events)
干预措施: Carboplatin (Drug)
Non Sarcopenic
Patients without sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events)
干预措施: Carboplatin (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Six weeks after the application of chemotherapy to detect changes from Baseline
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
次要结局
- Compare different formulas to calculate Glomerular Filtration Rate taking as gold standard cystatin c(Basal evaluation)
研究者
Oscar Gerardo Arrieta Rodríguez
Head of the Thoracic Oncology Unit and Laboratory of Experimental Oncology
Instituto Nacional de Cancerologia de Mexico