Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
7 juni 2022 uppdaterad av: Austrian Breast & Colorectal Cancer Study Group
- feasibility of physical activity
- increase of physical conversation
- Quality of Life (optional)
- vascular and metabolic effects
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
30
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Salzburg, Österrike, 5020
- Paracelsus Medical University Salzburg-Oncology, Coop. Group
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Carinthia
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St. Veit a. d. Glan, Carinthia, Österrike, 9330
- Hospital BHB St. Veit/Glan, Surgery
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Tyrol
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Innsbruck, Tyrol, Österrike, 6020
- Medical University Innsbruck, Internal Medicine
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Kufstein, Tyrol, Österrike, 6330
- District Hospital Kufstein
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Upper Austria
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Linz, Upper Austria, Österrike, 4020
- AKH Linz
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Wels, Upper Austria, Österrike, 4600
- Klinikum Wels-Grieskirchen
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Vorarlberg
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Rankweil, Vorarlberg, Österrike, 6830
- State Hospital Rankweil
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
subjects with localised colorectal carcinoma
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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ingen behandling
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
feasibility of physical activity
Tidsram: after 3 months
|
evaluation by frequency and duration of training interruptions or training discontinuations
|
after 3 months
|
|
feasibility of physical activity
Tidsram: after 6 months
|
evaluation by frequency and duration of training interruptions or training discontinuations
|
after 6 months
|
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feasibility of physical activity
Tidsram: after 12 months
|
evaluation by frequency and duration of training interruptions or training discontinuations
|
after 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
increase of physical efficiency
Tidsram: after 3 months
|
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
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after 3 months
|
|
increase of physical efficiency
Tidsram: after 6 months
|
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
|
after 6 months
|
|
increase of physical efficiency
Tidsram: after 12 months
|
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
|
after 12 months
|
|
Quality of Life scores
Tidsram: study start
|
optional evaluation by EORTC QLQ-C30 in several trial sites
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study start
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Quality of Life scores
Tidsram: after 3 months
|
optional evaluation by EORTC QLQ-C30 in several trial sites
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after 3 months
|
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Quality of Life scores
Tidsram: after 6 months
|
optional evaluation by EORTC QLQ-C30 in several trial sites
|
after 6 months
|
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Quality of Life scores
Tidsram: after 9 months
|
optional evaluation by EORTC QLQ-C30 in several trial sites
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after 9 months
|
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Quality of Life scores
Tidsram: after 12 months
|
optional evaluation by EORTC QLQ-C30 in several trial sites
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after 12 months
|
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vascular and metabolic effects
Tidsram: study start
|
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
|
study start
|
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vascular and metabolic effects
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Michael Fridrik, MD, Austrian Breast & Colorectal Cancer Study Group
- Studiestol: Alfred Fridrik, MD, Austrian Breast & Colorectal Cancer Study Group
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2010
Primärt slutförande (Faktisk)
1 april 2013
Avslutad studie (Faktisk)
1 april 2013
Studieregistreringsdatum
Först inskickad
23 september 2010
Först inskickad som uppfyllde QC-kriterierna
27 september 2010
Första postat (Uppskatta)
28 september 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Sjukdomsegenskaper
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Carcinom
- Kolorektala neoplasmer
- Upprepning
Andra studie-ID-nummer
- ABCSG C07
- Exercise (ABCSG)
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