Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

12 september 2019 bijgewerkt door: Chugai Pharma France

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.

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).

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

539

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
      • Paris, Frankrijk, 92042
        • Chugai Pharma France

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Dwarsdoorsnede

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Frequency of Cachexia According to Modified Fearon Criteria
Tijdsspanne: 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:

  • 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Frequency of the Different Stages of Cachexia in the General NSCLC Population
Tijdsspanne: Day 1

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%]
Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
Tijdsspanne: Day 1
Percentage of the different stages of cachexia at inclusion according to the NSCLC stage
Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
Tijdsspanne: Day 1
Percentage of the different stages of cachexia according to the NSCLC histology
Day 1
Frequency of Sarcopenia in the General NSCLC Patients With Cachexia
Tijdsspanne: Day 1
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
Tijdsspanne: 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.
Tijdsspanne: Day 1

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
Day 1
Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
Tijdsspanne: Day 1
NSCLC patients. 84 patients with missing data
Day 1
Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
Tijdsspanne: Day 1
Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).
Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
Tijdsspanne: Day 1
• 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
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
Tijdsspanne: Day 1
Blood glucose abnormalities according to the different stages of cachexia at inclusion
Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale
Tijdsspanne: 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.
Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT
Tijdsspanne: Day 1
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.
Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio
Tijdsspanne: Day 1
neutrophil/lymphocyte ratio
Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
Tijdsspanne: Day 1
CRP level
Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
Tijdsspanne: Day 1
fibrinogen level
Day 1
Description of the Quality of Life Associated With the Different Stages of Cachexia.
Tijdsspanne: 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
Day 1
Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
Tijdsspanne: Day 1

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
Day 1
Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms
Tijdsspanne: Day 1
Pharmacological treatment of cachexia or associated symptoms: Yes / No
Day 1
Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms
Tijdsspanne: Day 1
Non-pharmacological treatment of cachexia or associated symptoms: Y/N
Day 1
Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments
Tijdsspanne: Day 1
Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No
Day 1
Number of Participants With Diabetes Treatments
Tijdsspanne: Day 1
Diabetes treatments : Yes/No
Day 1
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
Tijdsspanne: Day 1
  • Proportion of patients with cachexia according to the subjective assessment of the clinician
  • Proportion of patients with cachexia according to the Fearon criteria
Day 1
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
Tijdsspanne: Day 1
  • 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?"
Day 1
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
Tijdsspanne: Day 1
  • 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.
Day 1

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chugai Pharma France

Medewerkers

French College of General Hospital Pneumologists (CPHG)
French-Speaking Association of Supportive Care in Cancer (AFSOS)
ITEC Services

Onderzoekers

  • Studie directeur: Luz Bobadilla, MD, Chugai Pharma France

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2016

Primaire voltooiing (Werkelijk)

1 oktober 2016

Studie voltooiing (Werkelijk)

1 oktober 2016

Studieregistratiedata

Eerst ingediend

17 november 2016

Eerst ingediend dat voldeed aan de QC-criteria

18 november 2016

Eerst geplaatst (Schatting)

21 november 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2019

Laatste update ingediend die voldeed aan QC-criteria

12 september 2019

Laatst geverifieerd

1 september 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CPF-ANA-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren