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POSITIVE - Study (Part III) Heidelberg (POSITIVE)

22 août 2018 mis à jour par: German Cancer Research Center

Physical Exercise Program in Lung Cancer Patients With Non-operable Disease Undergoing Palliative Treatment

The investigators plan to evaluate, in a randomized, controlled phase III trial in patients with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise intervention program (EIP) on quality of life, physical functioning and immune function parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases, Heidelberg, over a time period of two years and followed up for a total of 12 months.

Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus CMPC alone (besides a proper symptom and side effect management CMPC ensures the potential influence of social contacts that can be anticipated for the patients in the intervention group).

Our primary aims are to investigate whether a combination of a partly supervised (in- and outpatient) and partly home-based endurance and resistance training improves quality of life (QoL) and lowers levels of fatigue (evaluation via the standardized and validated questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on tumor specific immune responses. Biomarkers of immune function will be measured by cellular immunity and cytokine and chemokine panels.

Further secondary outcomes include measurement of anxiety, depression and demoralization, physical performance parameters (e.g. improvement in walk distance, muscle strength), as well as overall and progression free survival analyses.

The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in patients with advanced NSCLC with the results being utilized in the design of the here proposed trial.

The investigators hypothesize that patients randomized in the exercise intervention group will show improved QoL and reduced fatigue, as well as improved physical functioning and increased tumor specific immune responses.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

232

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Allemagne, 69126
        • Thoracic Oncology Clinic for Thoracic Diseases

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • NSCLC stage IIIB/IV
  • receiving systemic treatment (palliative radiotherapy accepted)
  • BMI > 18
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  • signed informed consent

Exclusion Criteria:

  • serious active infection (i.e. requiring an iv antibiotic, antifungal or antiviral agent)
  • inability to walk
  • immobility (more than two days)
  • previously untreated (non-irradiated or non-resected) symptomatic brain metastases;permitted are: (1) previously treated brain metastases [radiotherapy, surgery, dexamethasone dosage 8 mg per day, anti-epileptic therapy]; (2) asymptomatic brain metastases without additional therapy requirement
  • severe neurologic impairment (e.g. apoplectic insult, Morbus Parkinson, pareses of extremities)
  • severe cardiac impairment (e.g. cardiac insufficiency NYHA (New York Heart Association) > III, myocardial infarction within the last three months, unexplained syncopal events, severe cardiac arrhythmias, high grade aortic stenosis)
  • severe respiratory insufficiency
  • uncontrolled pain
  • abuse of alcohol or drugs reducing compliance to the study
  • bone metastasis inducing skeletal fragility
  • any circumstance that would impede ability to give informed consent or adherence to study requirements.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Exercise Intervention Program (EIP)

Inpatient periods: The combined resistance and endurance program consist of free weight and rubber band training for major upper and lower body muscle groups respectively of cycling/walking on an ergometer/treadmill 3x/week.

Outpatient periods (3x/week at least two/one supervised training sessions): Supervised training sessions in the local outpatient training center will comprise of resistance exercise on machines and endurance training on an ergometer/treadmill. For non-supervised training session during the outpatient period participants will receive an exercise manual for individualized home-based exercising.

In weekly phone calls, the advanced practice nurse will review adherence to the intervention and identify problems. Furthermore, the patients will also be asked the same questions as in the CMPC group.
Comportemental: Intervention d'exercice
Autre: Care-Management-Phone-Calls
Comparateur actif: Care-Management-Phone-Calls (CMPC)
Patients in this arm will receive a weekly "care-management-phone-call" (CMPC), performed by an advanced practice nurse (APN). The CMPCs are based on a structured questionnaire, reflecting pain, shortness of breath, disturbed sleep, exhaustion and distress and potentially treatment related side effects (e.g. infections, polyneuropathy, etc.). In case of demanding management of symptoms or complaints (e.g. uncontrolled pain or breathlessness) the treating physician is contacted by the APN to facilitate improvement.
Autre: Care-Management-Phone-Calls

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
QoL: Physical Well-Being (FACT-L)
Délai: assessed after 12 weeks of enrolement
The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire comprises of 36 items and deter-mines the quality of life in patients with lung cancer. It is separated in the subcategories "physical well-being" (PRIMARY OUTCOME), "emotional well-being", "social well-being", "functional well-being and disease-specific items". It is widely used in clinical studies and was already applied in exercise intervention studies in lung cancer patients
assessed after 12 weeks of enrolement
General Fatigue (MFI)
Délai: assessed after 12 weeks of enrolement
The MFI (Multidimensional Fatigue Inventory) questionnaire (20 items) evaluates the extent of chronic fatigue and is divided into the 5 subscales "general fatigue", "physical fatigue", "mental fatigue", "reduced motivation" and "reduced activity". The MFI questionnaire is widely used in oncological studies and an adequate number of comparative samples exists.
assessed after 12 weeks of enrolement

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Physical Performance (endurance and strength capacity)
Délai: assessed every 3 month after enrolement until month 12

6-Minute Walk Test (endurance capacity) The 6 minute walk test is feasible and safe to determine patients physical capacity. Patients are instructed to walk in 6 min. as many meters as possible with oxygen saturation and pulse rate being measured concomitantly.

Hand-held Dynamometry (isometric strength capacity) The hand-held dynamometry is a standardized instrument to measure muscular strength. In the study 6 major muscle groups of upper and lower extremities will be assessed for their isometric power.
assessed every 3 month after enrolement until month 12
Psychosocial Parameters (e.g. depression, anxiety, demoralization)
Délai: assessed every 3 month after enrolement until month 12

PHQ(Ultra-Brief Patient Health Questionnaire)-4 :

The PHQ-4 (Ultra-Brief Patient Health Questionnaire) questionnaire is a short instrument comprising of 4 items to detect the extent of depression and anxiety. It provides sufficient diagnostic accuracy for major depression and can be used as a screening instrument in cancer populations.

DS (Demoralization Scale) The demoralization scale (DS) is a relatively new developed questionnaire to detect the extent of existential distress in cancer patients. The German version was validated in 2011 and comprises of 24 questions. The results of the validation showed that the concept of demoralization is a useful instrument to describe the different states of existential distress and the individual incapacity to cope effectively with stressful situations.
assessed every 3 month after enrolement until month 12
Overall survival
Délai: for the period of 1 year after enrolement
for the period of 1 year after enrolement
progression-free survival
Délai: for the period of 1 year after enrolement
for the period of 1 year after enrolement

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Adverse Events
Délai: baseline until 6 month after enrolement
Safety analyses will be based on Adverse Events (AE´s), Severe Adverse Events (SAE´s), and Suspected Unexpected Serious Adverse Reaction (SUSARs) recorded during the study. Of particular interest are AEs, SAEs and SUSARs deemed to be potentially causally related to the endurance and resistance training.
baseline until 6 month after enrolement
Translational Program / Immunology
Délai: baseline, 3 & 6 month after enrolement

Quantification (Q) of immune cells: Multicolor flow cytometry from cryopreserved Peripheral Blood Mononuclear Cell (PBMC), CD (cluster of differentiation) 4+ and CD 8+ T cells, effector, naïve and activated T cells, regulatory T cells (Treg) and their functional subsets, natural killer cells, B cells, monocytes and monocyte-derived myeloid suppressor cells will be assessed.

Q. of tumor antigen reactive effector/memory T cells: Will be done by interferon gamma Enzyme Linked Immuno Spot Assays from PBMC using a panel of defined tumor antigens presented by generated autologous dendritic cells as antigen presenting cells and purified T cells as responder cells.

Detection of tumor reactive Treg: Will be done by established Treg specificity assay based on the increased suppressive activity of specifically activated regulatory T cells.

Q. of key immune effector molecules: Will be done for app. 14 different cytokines and chemokines from cryopreserved serum samples.
baseline, 3 & 6 month after enrolement

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

German Cancer Research Center

Collaborateurs

University Hospital Heidelberg
National Center for Tumor Diseases, Heidelberg

Les enquêteurs

  • Chercheur principal: Michael Thomas, Prof. Dr., Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg
  • Chercheur principal: Joachim Wiskemann, Dr., National Center for Tumor Diseases (NCT)
  • Chercheur principal: Simone Hummler, Dr., Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 décembre 2013

Achèvement primaire (Réel)

1 mars 2017

Achèvement de l'étude (Réel)

1 mars 2018

Dates d'inscription aux études

Première soumission

12 décembre 2013

Première soumission répondant aux critères de contrôle qualité

4 février 2014

Première publication (Estimation)

5 février 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 août 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • POSITIVE-III-S-326/2013

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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