Trial Outcomes & Findings for Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer. (NCT NCT02968979)
NCT ID: NCT02968979
Last Updated: 2019-09-24
Results Overview
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%).
COMPLETED
539 participants
Day1
2019-09-24
Participant Flow
56 oncologists, lung specialists or radiation oncologists treating patients with a malignant lung tumour have recruited patients from outpatient visit, day hospital or in-patient hospitalization in France and Belgium, between the 25th of July and the 31th of October 2016. Patients were recruited in a consecutive manner.
539 patients were recruited. Among them, 5 did not meet the eligibility criteria, 1 withdrew his/her consent, 2 were excluded during the data review because the cancer histology was undefined. The analysis population included 531 patients and among them 312 had skeletal muscle mass assessment.
Participant milestones
| Measure |
NSCLC Patient
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
|
|---|---|
|
Overall Study
STARTED
|
539
|
|
Overall Study
COMPLETED
|
531
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
NSCLC Patient
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
|
|---|---|
|
Overall Study
Protocol Violation
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Missing data for 202 patients
Baseline characteristics by cohort
| Measure |
NSCLC Patient
n=531 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
|
|---|---|
|
Age, Continuous
|
65.2 year
STANDARD_DEVIATION 10 • n=531 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=531 Participants
|
|
Sex: Female, Male
Male
|
353 Participants
n=531 Participants
|
|
Performance Status ECOG (Eastern Cooperative Oncology Group)
0
|
124 Participants
n=531 Participants
|
|
Performance Status ECOG (Eastern Cooperative Oncology Group)
1
|
300 Participants
n=531 Participants
|
|
Performance Status ECOG (Eastern Cooperative Oncology Group)
2
|
87 Participants
n=531 Participants
|
|
Performance Status ECOG (Eastern Cooperative Oncology Group)
3
|
19 Participants
n=531 Participants
|
|
Performance Status ECOG (Eastern Cooperative Oncology Group)
4
|
1 Participants
n=531 Participants
|
|
Smoking status
Non smoker
|
64 Participants
n=531 Participants
|
|
Smoking status
Past smoker
|
359 Participants
n=531 Participants
|
|
Smoking status
Current smoker
|
97 Participants
n=531 Participants
|
|
Smoking status
Missing
|
11 Participants
n=531 Participants
|
|
Histology type
Squamous cell carcinoma
|
140 Participants
n=531 Participants
|
|
Histology type
Adenocarcinoma
|
348 Participants
n=531 Participants
|
|
Histology type
Large cell carcinoma
|
18 Participants
n=531 Participants
|
|
Histology type
Others
|
25 Participants
n=531 Participants
|
|
Molecular abnormalities
EGFR, ALK, ROS1, BRAF or HER2
|
54 Participants
n=329 Participants • Missing data for 202 patients
|
|
Molecular abnormalities
K-RAS
|
61 Participants
n=329 Participants • Missing data for 202 patients
|
|
Molecular abnormalities
None
|
214 Participants
n=329 Participants • Missing data for 202 patients
|
|
Tumor stages
Stage I-II
|
34 Participants
n=504 Participants • Missing data for 27 patients
|
|
Tumor stages
Stage IIIA
|
21 Participants
n=504 Participants • Missing data for 27 patients
|
|
Tumor stages
Stage IIIB-IV
|
440 Participants
n=504 Participants • Missing data for 27 patients
|
|
Tumor stages
Unknown stage
|
9 Participants
n=504 Participants • Missing data for 27 patients
|
PRIMARY outcome
Timeframe: Day1Population: missing data for 84 patients
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%).
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=447 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of Cachexia According to Modified Fearon Criteria
|
173 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Missing data for 84 patients
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 \[22 kg/m² ≤ BMI and weight loss ≥ 15%\]
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=447 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population
No Cachexia
|
119 Participants
|
—
|
—
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population
Pre-Cachexia
|
151 Participants
|
—
|
—
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population
Cachexia
|
173 Participants
|
—
|
—
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population
Refractory Cachexia
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 81 patients
Percentage of the different stages of cachexia at inclusion according to the NSCLC stage
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=31 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=13 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=370 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
No Cachexia
|
9 Participants
|
3 Participants
|
95 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
Pre-Cachexia
|
10 Participants
|
5 Participants
|
124 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
Cachexia
|
11 Participants
|
5 Participants
|
148 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
Refractory Cachexia
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 84 patients
Percentage of the different stages of cachexia according to the NSCLC histology
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=116 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=296 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=35 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
No Cachexia
|
35 Participants
|
79 Participants
|
5 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
Pre-Cachexia
|
38 Participants
|
98 Participants
|
15 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
Cachexia
|
43 Participants
|
115 Participants
|
15 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
Refractory Cachexia
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Population with no missing data for the 3 interest criteria defining the cachexia
Percentage of patients with sarcopenia in the general NSCLC patients with cachexia
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=111 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of Sarcopenia in the General NSCLC Patients With Cachexia
|
74 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Population with no missing data for the 3 interest criteria defining the pre-cachexia
Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL\< 2%) in the general NSCLC patients with pre-cachexia:
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=89 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia
|
59 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients Overall number of patients analyzed for cachexia stage; 244 missing data.
Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC: * EGRF, ALK, ROS1, BRAF or HER2 * K-RAS * No mutation
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=46 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=58 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=183 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
No Cachexia
|
8 Participants
|
21 Participants
|
48 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
Pre-Cachexia
|
27 Participants
|
13 Participants
|
54 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
Cachexia
|
11 Participants
|
24 Participants
|
79 Participants
|
—
|
—
|
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
Refractory Cachexia
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1NSCLC patients. 84 patients with missing data
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=41 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=82 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=137 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=79 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
n=107 Participants
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
No Cachexia
|
6 Participants
|
18 Participants
|
42 Participants
|
26 Participants
|
27 Participants
|
|
Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
Pre-Cachexia
|
11 Participants
|
31 Participants
|
42 Participants
|
22 Participants
|
44 Participants
|
|
Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
Cachexia
|
24 Participants
|
32 Participants
|
50 Participants
|
31 Participants
|
36 Participants
|
|
Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
Refractory Cachexia
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients. 101 missing data
Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=39 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=133 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=378 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=79 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
No Cachexia
|
7 Participants
|
42 Participants
|
107 Participants
|
16 Participants
|
—
|
|
Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
Pre-Cachexia
|
16 Participants
|
50 Participants
|
121 Participants
|
42 Participants
|
—
|
|
Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
Cachexia
|
16 Participants
|
40 Participants
|
146 Participants
|
21 Participants
|
—
|
|
Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
Refractory Cachexia
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients
• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=31 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=63 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=35 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=6 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
n=68 Participants
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
No Cachexia
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
Pre-Cachexia
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
20 Participants
|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
Cachexia
|
29 Participants
|
60 Participants
|
21 Participants
|
3 Participants
|
37 Participants
|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
Refractory Cachexia
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 329 data missing
Blood glucose abnormalities according to the different stages of cachexia at inclusion
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=56 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=36 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=26 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
Pre-cachexia
|
20 Participants
|
15 Participants
|
12 Participants
|
—
|
—
|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
No cachexia
|
14 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
Cachexia
|
21 Participants
|
16 Participants
|
10 Participants
|
—
|
—
|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
Refractory cachexia
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 12 missing data
Dietary Intake Visual Analog Scale (Dietary intake VAS): The question "Could you indicate the amount you currently eat, placing a vertical mark on the line between "nothing at all" and "as usual"? ". Depending on the location of the patient mark on the scale, a score of between 0 ("nothing at all") and 10 ("as usual") will be allocated.
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=117 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=146 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=168 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=4 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale
|
9.57 score on a scale
Standard Deviation 1.07
|
7.68 score on a scale
Standard Deviation 2.64
|
6.51 score on a scale
Standard Deviation 2.89
|
3.13 score on a scale
Standard Deviation 1.16
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 9 missing data
Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=119 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=148 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=167 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=4 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT
|
40.00 score on a scale
Standard Deviation 3.90
|
35.09 score on a scale
Standard Deviation 7.02
|
32.60 score on a scale
Standard Deviation 7.16
|
25.75 score on a scale
Standard Deviation 10.05
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 112 missing data
neutrophil/lymphocyte ratio
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=86 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=113 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=132 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=4 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio
|
2.54 no unit (ratio)
Interval 1.9 to 3.87
|
2.73 no unit (ratio)
Interval 1.85 to 4.37
|
3.75 no unit (ratio)
Interval 2.0 to 6.14
|
7.15 no unit (ratio)
Interval 3.51 to 15.27
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 317 missing data
CRP level
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=27 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=37 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=64 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=2 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
|
18 mg/L
Interval 5.6 to 30.1
|
7 mg/L
Interval 3.0 to 25.0
|
21.5 mg/L
Interval 7.85 to 53.0
|
16.5 mg/L
Interval 15.0 to 18.0
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 387 missing data
fibrinogen level
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=17 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=18 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=25 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
|
4.58 g/L
Interval 3.93 to 5.3
|
4.75 g/L
Interval 3.9 to 5.9
|
4.96 g/L
Interval 4.5 to 6.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients Physical scale: 16 missing data Role scale: 17 missing data Cognitive scale: 16 missing data Emotional scale: 16 missing data Social scale: 18 missing data
Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=431 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=430 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=431 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=431 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
n=429 Participants
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Quality of Life Associated With the Different Stages of Cachexia.
No Cachexia
|
76.6 Scale score
Standard Deviation 20.1
|
77.6 Scale score
Standard Deviation 26.9
|
84.5 Scale score
Standard Deviation 21.0
|
82.0 Scale score
Standard Deviation 18.2
|
84.9 Scale score
Standard Deviation 21.3
|
|
Description of the Quality of Life Associated With the Different Stages of Cachexia.
Pre-Cachexia
|
67.0 Scale score
Standard Deviation 21.4
|
62.6 Scale score
Standard Deviation 32.5
|
79.7 Scale score
Standard Deviation 23.4
|
71.5 Scale score
Standard Deviation 25.1
|
72.0 Scale score
Standard Deviation 28.9
|
|
Description of the Quality of Life Associated With the Different Stages of Cachexia.
Cachexia
|
62.8 Scale score
Standard Deviation 24.5
|
56.2 Scale score
Standard Deviation 35.5
|
79.1 Scale score
Standard Deviation 22.3
|
68.1 Scale score
Standard Deviation 24.8
|
67.8 Scale score
Standard Deviation 31.7
|
|
Description of the Quality of Life Associated With the Different Stages of Cachexia.
Refractory Cachexia
|
13.3 Scale score
Standard Deviation 9.4
|
0.0 Scale score
Standard Deviation 0.0
|
83.3 Scale score
Standard Deviation 19.2
|
45.8 Scale score
Standard Deviation 35.0
|
12.5 Scale score
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 69 missing data
Three levels of physical activity are defined: 1. \- Low * No activity is reported OR * An activity is reported but does not reach moderate or high levels. 2. \- Moderate Corresponds to one of the following 3 criteria: * 3 or more days of intense activity lasting at least 20 min per day OR * 5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR * 5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week 3. \- High Corresponds to one of the following 2 criteria: * Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR * 7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=102 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=128 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=144 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=4 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
Moderate
|
34 Participants
|
42 Participants
|
39 Participants
|
0 Participants
|
—
|
|
Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
Low
|
30 Participants
|
56 Participants
|
78 Participants
|
4 Participants
|
—
|
|
Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
High
|
38 Participants
|
30 Participants
|
27 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 225 missing data
Pharmacological treatment of cachexia or associated symptoms: Yes / No
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=47 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=69 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=103 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=3 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NLSCS patients with a nutritional consultation within 2 months before inclusion 1 missing data
Non-pharmacological treatment of cachexia or associated symptoms: Y/N
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=25 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=42 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=80 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=3 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms
|
24 Participants
|
41 Participants
|
77 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 11 missing data
Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=118 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=148 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=166 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=4 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments
|
35 Participants
|
60 Participants
|
76 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients 6 missing data
Diabetes treatments : Yes/No
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=117 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=151 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=169 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=4 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
Number of Participants With Diabetes Treatments
|
9 Participants
|
15 Participants
|
20 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients Cachexia according to Investigator: 4 missing data Cachexia according to Fearon criteria: 84 missing data
* Proportion of patients with cachexia according to the subjective assessment of the clinician * Proportion of patients with cachexia according to the Fearon criteria
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=527 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=447 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
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 Participants
|
173 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients Anorexia according to Investigator: 3 missing data Anorexia according to VAS: 22 missing data Anorexia according to FAACT: 19 missing data Anorexia according to question 13 of QLQ-C30 questionnaire: 33 missing data
* Proportion of patients with anorexia according to the subjective assessment of the clinician * Proportion of patients with anorexia according to the Ingesta VAS * Proportion of patients with anorexia according to the AC/S-FAACT module score * Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: "Have you had a lack of appetite?"
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=528 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=509 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
n=512 Participants
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
n=498 Participants
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
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 Participants
|
166 Participants
|
273 Participants
|
219 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: NSCLC patients Severe malnutrition according to Investigator: 15 missing data Severe malnutrition according to the HAS: 416 missing data
* Proportion of patients with severe malnutrition according to the subjective assessment of the clinician * Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.
Outcome measures
| Measure |
NSCLC Patients With Cachexia
n=516 Participants
Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
|
Cancer Stage IIIA
n=115 Participants
Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
|
Cancer Stage IIIB- IV
Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
|
3 NSCLC Treatments
Patient with 3 cancer treatments received for NSCLC
|
at Least 4 NSCLC Treatments
Patient with at least 4 cancer treatments received for NSCLC
|
|---|---|---|---|---|---|
|
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 Participants
|
55 Participants
|
—
|
—
|
—
|
Adverse Events
No Safety Data Was Collected
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Luz BOBADILLA, Medical Affairs Director
CHUGAI PHARMA FRANCE
Results disclosure agreements
- Principal investigator is a sponsor employee The Study may not be published by the Health Institution or the Investigator without the prior written consent of the Promoter who has to respond as soon as possible. If the Investigator wishes to proceed with a publication or communication relating to the Study, the Promoter may, in the event that a serious and valid reason appears to require it, request that certain modifications be made. The modifications cannot in any way affect the scientific value of the publication.
- Publication restrictions are in place
Restriction type: OTHER