NCT02968979

Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer.

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 539 (actual)
• Sponsor: Chugai Pharma France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Non-small Cell Lung Cancer
• Cachexia

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-11-21
• Last updated: 2019-09-24
• Results posted: 2019-06-10

Locations

1 site across 1 country: France