Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 8
- 主要终点
- Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute's - Common Toxicity Criteria (NCI-CTC) v4.0
研究概览
简要总结
The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.
详细描述
However none of the studies relating body composition and chemotoxicity included elderly as a specific subpopulation. Furthermore in the majority of studies, body composition analyses are based on the estimation of muscle mass by CT scanner (axial L3 section). This method is to date not validated in the elderly cancer patients. Nevertheless some studies used Dual Energy X-ray Absorptiometry (DEXA), which is considered the gold standard in the assessment of body composition in older adults.
The investigators main hypothesis is that the appendicular muscle mass (I.e. muscle mass of the 4 limbs) operationalized as an index by dividing the muscle mass by squared height following Baumgartners' approach (Baumgartner, 1998) measured by DEXA (total of muscle mass of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly.
The finding that body composition is associated with poor tolerance of chemotherapy could lead to consider these parameters in the treatment decision of the elderly cancer patients and improve the current decision-making algorithms when treating older adults.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast, prostate, bladder, colo-rectal, ovarian cancers, and lymphoma
- •Metastatic or locally advanced neoplasm
- •Initiation of first line chemotherapy
- •Performance status World Health Organization (WHO) 0-3
- •Capacity to give a written informed consent
- •Life expectancy > 3 mouths
排除标准
- •Concomitant targeted therapy
- •Concomitant targeted radiotherapy
- •Height > 196 cm, weight > 136 kg (DEXA not feasible)
- •Hemopathy excluding lymphoma
- •Cognitive impairment compromising the well proceeding and security of the study
- •Cognitive impairment compromising the obtaining of a written informed consent
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute's - Common Toxicity Criteria (NCI-CTC) v4.0
时间窗: Up to 12 months
Toxicity event defined by : first occurrence of grade 4 hematologic or grade 3-4 non hematologic toxicity as defined by the National Cancer Institute-Common Toxicity Criteria (NCI-CTC version 4) and/or disruption of chemotherapy because of inacceptable toxicity.
次要结局
- Quality of life impairment(Up to 12 months)
- Functional autonomy impairment(Up to 12 months)
- Functional physical performances impairment(Up to 12 months)
- Early death(Up to 12 months)