Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
7. juni 2022 oppdatert av: Austrian Breast & Colorectal Cancer Study Group
- feasibility of physical activity
- increase of physical conversation
- Quality of Life (optional)
- vascular and metabolic effects
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
30
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Salzburg, Østerrike, 5020
- Paracelsus Medical University Salzburg-Oncology, Coop. Group
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Carinthia
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St. Veit a. d. Glan, Carinthia, Østerrike, 9330
- Hospital BHB St. Veit/Glan, Surgery
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Tyrol
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Innsbruck, Tyrol, Østerrike, 6020
- Medical University Innsbruck, Internal Medicine
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Kufstein, Tyrol, Østerrike, 6330
- District Hospital Kufstein
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Upper Austria
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Linz, Upper Austria, Østerrike, 4020
- AKH Linz
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Wels, Upper Austria, Østerrike, 4600
- Klinikum Wels-Grieskirchen
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Vorarlberg
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Rankweil, Vorarlberg, Østerrike, 6830
- State Hospital Rankweil
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
ingen behandling
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Michael Fridrik, MD, Austrian Breast & Colorectal Cancer Study Group
- Studiestol: Alfred Fridrik, MD, Austrian Breast & Colorectal Cancer Study Group
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006 Aug 1;24(22):3527-34. doi: 10.1200/JCO.2006.06.0855. Epub 2006 Jul 5.
- Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H, Whittom R, Hantel A, Schilsky RL, Fuchs CS. Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol. 2006 Aug 1;24(22):3535-41. doi: 10.1200/JCO.2006.06.0863. Epub 2006 Jul 5.
- Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.
- Demark-Wahnefried W. Cancer survival: time to get moving? Data accumulate suggesting a link between physical activity and cancer survival. J Clin Oncol. 2006 Aug 1;24(22):3517-8. doi: 10.1200/JCO.2006.06.6548. Epub 2006 Jul 5. No abstract available.
- Jackson AS, Pollock ML. Generalized equations for predicting body density of men. Br J Nutr. 1978 Nov;40(3):497-504. doi: 10.1079/bjn19780152.
- Hoeger W, Hoeger S. Principles and Labs for Physical Fitness. Morton Publishing Company, first edition 1999
- O'Donovan G, Owen A, Bird SR, Kearney EM, Nevill AM, Jones DW, Woolf-May K. Changes in cardiorespiratory fitness and coronary heart disease risk factors following 24 wk of moderate- or high-intensity exercise of equal energy cost. J Appl Physiol (1985). 2005 May;98(5):1619-25. doi: 10.1152/japplphysiol.01310.2004. Epub 2005 Jan 7.
- Haber Paul. Leitfaden zur medizinischen Trainingsberatung - Rehabilitation bis Leistungssport. 3. Auflage 2009; Springer Wien New York
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2010
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. april 2013
Datoer for studieregistrering
Først innsendt
23. september 2010
Først innsendt som oppfylte QC-kriteriene
27. september 2010
Først lagt ut (Anslag)
28. september 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juni 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juni 2022
Sist bekreftet
1. juni 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Sykdomsattributter
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Karsinom
- Kolorektale neoplasmer
- Tilbakefall
Andre studie-ID-numre
- ABCSG C07
- Exercise (ABCSG)
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