- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Rekruttering
- Institut Universitaire de cardiologie et de pneumologie de Quebec
-
Ta kontakt med:
- Didier Saey, PhD
- Telefonnummer: 2614 418-656-8711
- E-post: didier.saey@criucpq.ulaval.ca
-
Hovedetterforsker:
- Didier Saey, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
|
Hva måler studien?
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)
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Didier Saey, PhD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20878
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