- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01136083
Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an essential process for tumoral growth and metastasis. This process is dependent on the balance between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated with myostatin overexpression in cancer. Exercise training can depress tumor growth and suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and some animal studies. The purpose of this study is mainly to investigate the effects of exercise training on
- circulating VEGF-A
- muscle growth and function
- Myostatin
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taipei City, Taïwan, 100
- National Taiwan University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 40-75 years
- Advanced NSCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Targeted therapy for at least 8 weeks
- Stable condition
Exclusion Criteria:
- Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise
- Do not understand the verbal or written instructions
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Exercise training
Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.
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Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.
Autres noms:
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Comparateur actif: Control group
Subjects in control group will not undergo individualized high aerobic interval training on treadmill.
They will receive usual care as normally does in hospital.
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Subjects in control group will not undergo individualized high aerobic interval training on treadmill.
They will receive usual care as normally does in hospital.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Exercise capacity
Délai: 8 weeks after the start of the intervention
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Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
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8 weeks after the start of the intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Imaging of muscle
Délai: 8 weeks and 16 weeks after the start of the intervention
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Measured by MRS
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8 weeks and 16 weeks after the start of the intervention
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Analysis of venous blood sample
Délai: 8 weeks andd 16 weeks after the start of the intervention
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Analysis of circulating VEGF-A and myostatin
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8 weeks andd 16 weeks after the start of the intervention
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Quality of life
Délai: baseline, 8 weeks, 16 weeks
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Measured by questionnaire
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baseline, 8 weeks, 16 weeks
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Exercise capacity
Délai: 16 weeks after the start of the intervention
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Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
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16 weeks after the start of the intervention
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Muscle function
Délai: 8 weeks and 16 weeks after the start of the intervention
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Isokinetic muscle strength and endurance with Biodex
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8 weeks and 16 weeks after the start of the intervention
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Physical activity
Délai: 8 weeks andd 16 weeks after the start of the intervention
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Measured with 7-day recall questionnaire
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8 weeks andd 16 weeks after the start of the intervention
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Dietary intake
Délai: 8 weeks andd 16 weeks after the start of the intervention
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Measured with 24-hour recall questionnaire
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8 weeks andd 16 weeks after the start of the intervention
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Body composition
Délai: 8 weeks andd 16 weeks after the start of the intervention
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Body mass index calculated with body weight and height % body fat abd free-fat mass with BIA |
8 weeks andd 16 weeks after the start of the intervention
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201003064R
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