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

NCT02968979 | Completed Results

• 1 other identifier: CPF-ANA-001
• Study Type: observational
• Target: 539
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer; Cachexia

Keywords

Cachexia; Non-Small Cell Lung cancer; Anorexia; Malnutrition

Outcome Measures

Primary Outcomes (1)

• Frequency of Cachexia According to Modified Fearon Criteria

  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%).

  Day1

Secondary Outcomes (24)

• 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 Stage Associated With NSCLC.

  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 in the General NSCLC Patients With Cachexia

  Day 1

• Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with non-small cell lung cancer (NSCLC) from outpatient visit, Day Hospital or in-patient hospitalization.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chugai Pharma France: lead
• French College of General Hospital Pneumologists (CPHG): collaborator
• French-Speaking Association of Supportive Care in Cancer (AFSOS): collaborator
• ITEC Services: collaborator

Study Sites (1)

Chugai Pharma France

Paris, 92042, France

Location

Related Publications (1)

• 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.

  PMID: 21296615 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Cachexia; Anorexia; Malnutrition

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr Luz BOBADILLA, Medical Affairs Director
• Organization: CHUGAI PHARMA FRANCE

bobadilla@chugai-pharm.fr

+33 1 56 37 05 28

Study Officials

• Luz Bobadilla, MD

  Chugai Pharma France

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 24, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)