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Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma

7. juni 2022 opdateret af: Austrian Breast & Colorectal Cancer Study Group
  • feasibility of physical activity
  • increase of physical conversation
  • Quality of Life (optional)
  • vascular and metabolic effects

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

In this phase II pilot project the feasibility of a defined medical physical activity should be verified for increased physical conversation. The study is conducted multicentric (single group) with a study population of 30 patients. After completion of adjuvant chemotherapy the patients will participate a defined physical training, 3 times per week within a time period of 52 weeks. Planned study duration 2 years.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Østrig
      • Salzburg, Østrig, 5020
        • Paracelsus Medical University Salzburg-Oncology, Coop. Group
    • Carinthia
      • St. Veit a. d. Glan, Carinthia, Østrig, 9330
        • Hospital BHB St. Veit/Glan, Surgery
    • Tyrol
      • Innsbruck, Tyrol, Østrig, 6020
        • Medical University Innsbruck, Internal Medicine
      • Kufstein, Tyrol, Østrig, 6330
        • District Hospital Kufstein
    • Upper Austria
      • Linz, Upper Austria, Østrig, 4020
        • AKH Linz
      • Wels, Upper Austria, Østrig, 4600
        • Klinikum Wels-Grieskirchen
    • Vorarlberg
      • Rankweil, Vorarlberg, Østrig, 6830
        • State Hospital Rankweil

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

subjects with localised colorectal carcinoma

Beskrivelse

Inclusion Criteria:

  • complete resected, histologically confirmed adeno carcinoma of colon or rectal and condition after (neo-)adjuvant therapy either in (1) stage III or (2) stage II with risk factor
  • 4-16 weeks after the end of an adjuvant chemotherapy
  • ECOG 0,1
  • Age > 18 years
  • adequate liver-, nephro- and hemogram parameters
  • physical eligibility

Exclusion Criteria:

  • significant comorbidities which exclude the participation
  • evidence of local recurrence or distant metastases
  • non-compliance of subject
  • other malignancy within the last 5 years (except: skin basalioma, cervix carcinoma in situ)
  • clinically significant cardiovascular diseases
  • treatment with beta blocker without possibility of adjustment
  • left bundle-branch block
  • simultaneous chemotherapy or radiotherapy
  • pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
ingen behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
feasibility of physical activity
Tidsramme: after 3 months
evaluation by frequency and duration of training interruptions or training discontinuations
after 3 months
feasibility of physical activity
Tidsramme: after 6 months
evaluation by frequency and duration of training interruptions or training discontinuations
after 6 months
feasibility of physical activity
Tidsramme: after 12 months
evaluation by frequency and duration of training interruptions or training discontinuations
after 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
increase of physical efficiency
Tidsramme: after 3 months
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
after 3 months
increase of physical efficiency
Tidsramme: after 6 months
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
after 6 months
increase of physical efficiency
Tidsramme: after 12 months
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
after 12 months
Quality of Life scores
Tidsramme: study start
optional evaluation by EORTC QLQ-C30 in several trial sites
study start
Quality of Life scores
Tidsramme: after 3 months
optional evaluation by EORTC QLQ-C30 in several trial sites
after 3 months
Quality of Life scores
Tidsramme: after 6 months
optional evaluation by EORTC QLQ-C30 in several trial sites
after 6 months
Quality of Life scores
Tidsramme: after 9 months
optional evaluation by EORTC QLQ-C30 in several trial sites
after 9 months
Quality of Life scores
Tidsramme: after 12 months
optional evaluation by EORTC QLQ-C30 in several trial sites
after 12 months
vascular and metabolic effects
Tidsramme: study start
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
study start
vascular and metabolic effects
Tidsramme: after 3 months
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
after 3 months
vascular and metabolic effects
Tidsramme: after 12 months
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
after 12 months
changes of cytokines and adiponectines
Tidsramme: study start
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
study start
changes of cytokines and adiponectines
Tidsramme: after 3 months
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
after 3 months
changes of cytokines and adiponectines
Tidsramme: after 12 months
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
after 12 months
gen- and metabolic signs
Tidsramme: study start
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
study start
gen- and metabolic signs
Tidsramme: after 3 months
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
after 3 months
gen- and metabolic signs
Tidsramme: after 12 months
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
after 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Efterforskere

  • Studiestol: Michael Fridrik, MD, Austrian Breast & Colorectal Cancer Study Group
  • Studiestol: Alfred Fridrik, MD, Austrian Breast & Colorectal Cancer Study Group

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

23. september 2010

Først indsendt, der opfyldte QC-kriterier

27. september 2010

Først opslået (Skøn)

28. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABCSG C07
  • Exercise (ABCSG)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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