- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02968979
Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer. (CacheMire)
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 92042
- Chugai Pharma France
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Cachexia According to Modified Fearon Criteria
Time Frame: Day1
|
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:
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of the Different Stages of Cachexia in the General NSCLC Population
Time Frame: Day 1
|
Percentage of the different stages of cachexia at inclusion. The different stages of cachexia used the following classification:
|
Day 1
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
Time Frame: Day 1
|
Percentage of the different stages of cachexia at inclusion according to the NSCLC stage
|
Day 1
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Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
Time Frame: Day 1
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Percentage of the different stages of cachexia according to the NSCLC histology
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Day 1
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Frequency of Sarcopenia in the General NSCLC Patients With Cachexia
Time Frame: Day 1
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Percentage of patients with 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
Time Frame: Day 1
|
Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL< 2%) in the general NSCLC patients with pre-cachexia:
|
Day 1
|
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
Time Frame: Day 1
|
Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC:
|
Day 1
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Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
Time Frame: Day 1
|
NSCLC patients.
84 patients with missing data
|
Day 1
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Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
Time Frame: Day 1
|
Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).
|
Day 1
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Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
Time Frame: Day 1
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• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.
|
Day 1
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Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
Time Frame: Day 1
|
Blood glucose abnormalities according to the different stages of cachexia at inclusion
|
Day 1
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Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale
Time Frame: Day 1
|
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.
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Day 1
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Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT
Time Frame: Day 1
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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.
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Day 1
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Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio
Time Frame: Day 1
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neutrophil/lymphocyte ratio
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Day 1
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Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
Time Frame: Day 1
|
CRP level
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Day 1
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Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
Time Frame: Day 1
|
fibrinogen level
|
Day 1
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Description of the Quality of Life Associated With the Different Stages of Cachexia.
Time Frame: Day 1
|
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
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Day 1
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Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
Time Frame: Day 1
|
Three levels of physical activity are defined:
Corresponds to one of the following 2 criteria:
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Day 1
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Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms
Time Frame: Day 1
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Pharmacological treatment of cachexia or associated symptoms: Yes / No
|
Day 1
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Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms
Time Frame: Day 1
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Non-pharmacological treatment of cachexia or associated symptoms: Y/N
|
Day 1
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Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments
Time Frame: Day 1
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Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No
|
Day 1
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Number of Participants With Diabetes Treatments
Time Frame: Day 1
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Diabetes treatments : Yes/No
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Day 1
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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
Time Frame: Day 1
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Day 1
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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
Time Frame: Day 1
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Day 1
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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
Time Frame: Day 1
|
|
Day 1
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Luz Bobadilla, MD, Chugai Pharma France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Nutrition Disorders
- Body Weight
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Body Weight Changes
- Emaciation
- Weight Loss
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Wasting Syndrome
- Cachexia
Other Study ID Numbers
- CPF-ANA-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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