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

12 de septiembre de 2019 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

539

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Francia
      • Paris, Francia, 92042
        • Chugai Pharma France

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Transversal

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Frequency of Cachexia According to Modified Fearon Criteria
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Frequency of the Different Stages of Cachexia in the General NSCLC Population
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 1
neutrophil/lymphocyte ratio
Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
Periodo de tiempo: Day 1
CRP level
Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
Periodo de tiempo: Day 1
fibrinogen level
Day 1
Description of the Quality of Life Associated With the Different Stages of Cachexia.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 1
Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No
Day 1
Number of Participants With Diabetes Treatments
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Chugai Pharma France

Colaboradores

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

Investigadores

  • Director de estudio: Luz Bobadilla, MD, Chugai Pharma France

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2016

Finalización primaria (Actual)

1 de octubre de 2016

Finalización del estudio (Actual)

1 de octubre de 2016

Fechas de registro del estudio

Enviado por primera vez

17 de noviembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

18 de noviembre de 2016

Publicado por primera vez (Estimar)

21 de noviembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de septiembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

12 de septiembre de 2019

Última verificación

1 de septiembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CPF-ANA-001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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