Clinical trial NCT02968979: Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Cachexia
Keywords: Cachexia
Non-Small Cell Lung cancer
Anorexia
Malnutrition
Lead sponsor: Chugai Pharma France
Sponsor class: INDUSTRY
Collaborators: name: French College of General Hospital Pneumologists (CPHG)
name: French-Speaking Association of Supportive Care in Cancer (AFSOS)
name: ITEC Services
First posted: 2016-11-21
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with non-small cell lung cancer (NSCLC) from outpatient visit, Day Hospital or in-patient hospitalization.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Frequency of Cachexia According to Modified Fearon Criteria
timeFrame: Day1
Secondary outcomes:
measure: Frequency of the Different Stages of Cachexia in the General NSCLC Population
timeFrame: Day 1
measure: Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
timeFrame: Day 1
measure: Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
timeFrame: Day 1
measure: Frequency of Sarcopenia in the General NSCLC Patients With Cachexia
timeFrame: Day 1
measure: Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia
timeFrame: Day 1
measure: Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
timeFrame: Day 1
measure: Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
timeFrame: Day 1
measure: Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
timeFrame: Day 1
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
timeFrame: Day 1
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
timeFrame: Day 1
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale
timeFrame: Day 1
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT
timeFrame: Day 1
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio
timeFrame: Day 1
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
timeFrame: Day 1
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
timeFrame: Day 1
measure: Description of the Quality of Life Associated With the Different Stages of Cachexia.
timeFrame: Day 1
measure: Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
timeFrame: Day 1
measure: Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms
timeFrame: Day 1
measure: Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms
timeFrame: Day 1
measure: Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments
timeFrame: Day 1
measure: Number of Participants With Diabetes Treatments
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Chugai Pharma France
Study officials:
affiliation: Chugai Pharma France
name: Luz Bobadilla, MD
role: STUDY_DIRECTOR
References:
citation: Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.