N/A
N=539
Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer.
Non-small Cell Lung Cancer · Cachexia
Bottom Line
View on ClinicalTrials.gov: NCT02968979 ↗Enrolled (actual)
539
Serious AEs
—
Results posted
Jun 2019
Primary outcome: Primary: Frequency of Cachexia According to Modified Fearon Criteria — 173 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chugai Pharma France
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Cachexia According to Modified Fearon Criteria |
173 | — |
| SECONDARY Frequency of the Different Stages of Cachexia in the General NSCLC Population |
119; 151; 173; 4 | — |
| SECONDARY Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC. |
9; 3; 95; 10; 5; 124 | — |
| SECONDARY Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC. |
35; 79; 5; 38; 98; 15 | — |
| SECONDARY Frequency of Sarcopenia in the General NSCLC Patients With Cachexia |
74 | — |
| SECONDARY Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia |
59 | — |
| SECONDARY Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC. |
8; 21; 48; 27; 13; 54 | 0.0032 sig |
| SECONDARY Frequency of the Different Stages of Cachexia According to the Number of Treatments Received. |
6; 18; 42; 26; 27; 11 | — |
| SECONDARY Frequency of the Different Stages of Cachexia According to the Types of Treatments Received. |
7; 42; 107; 16; 16; 50 | — |
| SECONDARY Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State |
0; 0; 5; 2; 8; 0 | — |
| SECONDARY Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose |
14; 5; 4; 20; 15; 12 | — |
| SECONDARY Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale |
9.57; 7.68; 6.51; 3.13 | — |
| SECONDARY Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT |
40.00; 35.09; 32.60; 25.75 | — |
| SECONDARY Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio |
2.54; 2.73; 3.75; 7.15 | — |
| SECONDARY Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP |
18; 7; 21.5; 16.5 | — |
| SECONDARY Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen |
4.58; 4.75; 4.96 | — |
| SECONDARY Description of the Quality of Life Associated With the Different Stages of Cachexia. |
76.6; 77.6; 84.5; 82.0; 84.9; 67.0 | <0.0001 sig |
| SECONDARY Description of the Level of Physical Activity Associated With the Different Stages of Cachexia. |
30; 56; 78; 4; 34; 42 | — |
| SECONDARY Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms |
0; 0; 1; 0 | — |
| SECONDARY Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms |
24; 41; 77; 3 | — |
| SECONDARY Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments |
35; 60; 76; 3 | — |
| SECONDARY Number of Participants With Diabetes Treatments |
9; 15; 20; 0 | — |
| SECONDARY 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 |
53; 173 | — |
| SECONDARY 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 |
109; 166; 273; 219 | — |
| SECONDARY 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 |
52; 55 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02968979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.