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

12 de setembro de 2019 atualizado 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).

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

539

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • França
      • Paris, França, 92042
        • Chugai Pharma France

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: Coorte
  • Perspectivas de Tempo: Transversal

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Frequency of Cachexia According to Modified Fearon Criteria
Prazo: 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 resultados secundários

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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Chugai Pharma France

Colaboradores

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

Investigadores

  • Diretor de estudo: Luz Bobadilla, MD, Chugai Pharma France

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2016

Conclusão Primária (Real)

1 de outubro de 2016

Conclusão do estudo (Real)

1 de outubro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

17 de novembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de novembro de 2016

Primeira postagem (Estimativa)

21 de novembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de setembro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de setembro de 2019

Última verificação

1 de setembro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CPF-ANA-001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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