Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 539
- 试验地点
- 1
- 主要终点
- Frequency of Cachexia According to Modified Fearon Criteria
研究概览
简要总结
The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC).
详细描述
This is a cross-sectional, non-interventional, European (France and Belgium), multicentric prevalence study, conducted on a representative population of 500 patients with NSCLC, to assess the frequency and the management of cachexia and associated symptoms.
The study will be conducted in accordance with the professional code of ethics and the good epidemiological practices guidelines developed by the ADELF (the Association of French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the drafting of reports and publications related to the study.
The information will be collected during a single visit to the oncologist/lung specialist as part of the usual patient management of his/her lung cancer. The physician will explain the purpose of the study to the patient with an information form specific to the study and will inform him/her of the option to refuse or withdraw from participation. The patient information form in France or a specific consent form in Belgium will be signed by the patient and a copy will be given to him/her (the original will be kept by the physician).
This study does not require any additional specific data. Data will come from the medical file and from the routine disease management. Furthermore, the following self-completion questionnaires will be proposed to patients: Visual analogue scale for dietary intake (dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia (Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy [FAACT] questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ, International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be collected for assessment of skeletal muscle mass index at L3.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patient 18 years of age and older
- •Patient with NSCLC
- •Patient who has been informed of the study and who has signed a patient information leaflet for France or an informed consent for Belgium
- •Patient able to complete a self-assessment questionnaire
排除标准
- •Patient unable to consent and/or unable to sign the patient information form in France or an informed consent in Belgium
- •Patient with a complete resection of an early stage NSCLC
- •History of head and neck cancer
结局指标
主要结局
Frequency of Cachexia According to Modified Fearon Criteria
时间窗: Day1
Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity. A patient was considered to have cachexia if he/she had: * Weight loss \>5% in the last 6 months prior to inclusion or * BMI \<20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or * Weight loss \>2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions. In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI \<20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).
次要结局
- Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.(Day 1)
- Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State(Day 1)
- Frequency of the Different Stages of Cachexia in the General NSCLC Population(Day 1)
- Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.(Day 1)
- Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio(Day 1)
- Frequency of Sarcopenia in the General NSCLC Patients With Cachexia(Day 1)
- Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.(Day 1)
- Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia(Day 1)
- Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.(Day 1)
- Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP(Day 1)
- Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.(Day 1)
- Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose(Day 1)
- Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale(Day 1)
- Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.(Day 1)
- Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments(Day 1)
- Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia(Day 1)
- Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia(Day 1)
- Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition(Day 1)
- Description of the Quality of Life Associated With the Different Stages of Cachexia.(Day 1)
- Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms(Day 1)
- Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms(Day 1)
- Number of Participants With Diabetes Treatments(Day 1)
- Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT(Day 1)
- Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen(Day 1)