- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Taipei City, Taiwan, 100
- National Taiwan University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Actieve vergelijker: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Exercise capacity
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Imaging of muscle
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 201003064R
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