- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01885754
Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer
Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer.
Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown.
Aim: To explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether they have cachexic state at diagnosis.
Methods: This study will be conducted at the Institut universitaire de cardiologie et de pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated whether or not they have a cachexic state. The evaluation will need two visits separated by 5 days.
During the evaluation the following tests will be done:
- Anthropometric measures
- Level of daily physical activity
- Pulmonary function test
- Maximal incremental cardiopulmonary exercise test on ergocycle
- Endurance test on ergocycle
- Muscle function tests
- Magnetic stimulation
- Quadriceps biopsy
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
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Quebec
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Québec, Quebec, Canada, G1V 4G5
- Rekruttering
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
-
Kontakt:
- Didier Saey, PhD
- Telefonnummer: 2614 418-656-8711
- E-mail: didier.saey@criucpq.ulaval.ca
-
Ledende efterforsker:
- Didier Saey, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Men and women with a primary lung cancer diagnosis
Exclusion Criteria:
- Already have undertaken surgery, chemotherapy or radiotherapy treatment
- Having an other cancer in the last five years
- Taking anticoagulation therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Lung cancer patient with cachexia
Muscle lumbar area < 55cm2/m2 for men and < 39 cm2/m2 for women
|
Lung cancer patients without cachexia
Muscle lumbar area over 55cm2/m2 for men and 39 cm2/m2 for women
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximal quadriceps strength
Tidsramme: 1 day (at the time of the diagnosis before any treatment)
|
1 day (at the time of the diagnosis before any treatment)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Exercise capacity
Tidsramme: 1 day (at the time of the diagnosis before any treatment)
|
1 day (at the time of the diagnosis before any treatment)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Didier Saey, PhD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20878
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Kliniske forsøg med Non-Small-cell Lung Cancer
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AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
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Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien