Body Mass Index (BMI) and Quality of Life (QoL) in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,380
- 试验地点
- 1
- 主要终点
- relationship between BMI and health-related quality-of-life scores according to tumor stage
研究概览
简要总结
BMI is a simple and widely recorded variable that may capture obesity or cachexia in cancer patients. How BMI is associated to health-related quality of life (HR-QoL) in such patients is poorly investigated.
High BMI may be associated to obesity, an increased burden of comorbidity, reduced physical activity and, in some settings, to more aggressive oncological disease. On the other hand, low BMI may reflect enhanced weight loss, cachectic syndrome, higher tumor burden and adverse prognostic features which all deteriorate quality of life. The aim of the present study is to evaluate the association of BMI and HR-QoL as measured by the EORTC-QLQ-C30 or the EQ-5D-5L questionnaire in several cancer settings (such as localized vs metastatic or distinct primary tumors).
详细描述
Health-related quality of life (HRQoL) might have a varied association with body weight in patients with solid cancer[1].
On one hand, low body weight may reflect cancer-related anorexia and weight loss and cachectic syndrome, which are associated with impaired performance status, deteriorated general conditions, and advanced cancer[2]. In such patients, the probability of recording a low Body Mass Index (BMI) and, concomitantly, an inferior health-related quality of life (HRQoL, as a patient reported outcome, PRO) is high.
On the other hand, some of the hormonal mediators found at increased concentration in obese patients, such as insulin-like growth factor (IGF), have been demonstrated to be involved in biological pathways that favor improved HRQoL[3].
An additional apparent contradiction is that obesity and high BMI may represent in some cancer settings an adverse feature. In particular, obesity is associated with an increased risk of developing certain tumor types and, in some cancer patients with radically resected primary tumors, of cancer relapse[4]. Moreover high BMI is often associated with an increased burden of comorbidity (e.g. cardiovascular and metabolic diseases)[5] and reduced physical activity. All these factors may reduce HRQoL.
Studies investigating specific associations between BMI and HRQoL in specific cancer settings are therefore warranted.
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
- •Histologically confirmed diagnosis of solid tumor
- •Age >18 years
- •Signed informed consent
- •Life expectancy > 12 weeks
排除标准
- •Inability to fill out the questionnaires.
- •Absence of a certain diagnosis of solid tumor (e.g. subjects on screening programs)
- •Diagnosis of second malignancies that might bias results interpretation
研究组 & 干预措施
patients with solid tumor
All consecutive patients with a histologically confirmed diagnosis of solid tumor referred to any of the Medical Oncology Units of the S.I.C.O.G. cooperative group (http://www.sicog.it/).
结局指标
主要结局
relationship between BMI and health-related quality-of-life scores according to tumor stage
时间窗: Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient
To assess the relationship between BMI and health-related quality-of-life scores in localized vs metastatic cancer patients
次要结局
- relationship between BMI and health-related quality-of-life scores according to different clinical settings other than stage(Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient)
研究者
Vincenzo Formica
Consultant in Medical Oncology, Principal Investigator
University of Rome Tor Vergata