Clinical trial · Observational
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.
NCT02968979CI-TRIAL-00040802CacheMirecompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Frequency of Cachexia According to Modified Fearon Criteria
- timeFrame
- Day1
- description
- 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%).
Secondary outcomes (24)
- measure
- Frequency of the Different Stages of Cachexia in the General NSCLC Population
- timeFrame
- Day 1
- description
- Percentage of the different stages of cachexia at inclusion. The different stages of cachexia used the following classification: * No Cachexia: 1) no weight loss (WL\<2%) or 2) weight gain AND no anorexia AND no sarcopenia * The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss \< 2% AND sarcopenia * Cachexia: 1) Weight loss \> 5% OR 2) weight loss between 2 and 5% AND BMI \< 20 kg/m² OR 3) weight loss \> 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage * Refractory cachexia: ECOG 3 or 4 AND low survival expectancy \[BMI \< 20kg/m² and weight loss ≥ 6%\] OR \[20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%\] OR \[22 kg/m² ≤ BMI and weight loss ≥ 15%\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDFearon 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