Tertiary Prevention by Exercise in Colorectal Cancer Therapy (F-PROTECT)
24. november 2017 oppdatert av: Technical University of Munich
Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)
The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.
Studieoversikt
Detaljert beskrivelse
Apart from a genetic predisposition lifestyle factors (low physical activity, nutrition, and obesity) increase the risk of colorectal cancer.
Furthermore, in observational studies increased physical activity has shown to improve the prognosis in patients after the diagnosis of colorectal cancer.
However, there are currently no prospective randomized controlled trials which prove the causal relationship between exercise and prognosis in colorectal cancer patients.
The long-term aim of this study is to evaluate whether physical activity of ≥ 18 MET-h (Metabolic equivalent task-hours) per week significantly improves disease free survival in colorectal cancer survivors (stage UICC II/III).
In the first instance, structure-, process- as well as outcome-characteristics need to be investigated within a feasibility study (F-PROTECT).
Essential aims are to establish collaborations with clinics and training centres, to achieve the required recruitment numbers, and to conduct the training intervention.
Studietype
Intervensjonell
Registrering (Faktiske)
50
Fase
- Ikke aktuelt
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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Munich, Tyskland, 80809
- Department of Medicine, Division of Prevention and Sports Medicine TU Munich
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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
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- histologically confirmed nonhereditary primary Stage II or III colon cancer diagnosis or rectal cancer
- written informed consent in German
- histopathologically confirmed R0-resection
- start of guideline conformed adjuvant chemotherapy within 12 weeks after R0-resection in Stage III colon cancer diagnosis (if necessary in Stage III colon cancer diagnosis)
Exclusion Criteria:
- hereditary colon cancer diagnosis
- R1 and R2 resection
- clinically relevant complications during recovery
- secondary neoplasm
- non-continuance of guideline conformed therapy
- uncontrolled infection
- manifest cardiac disease (e.g. unstable CAD, heart failure (NYHA IV), malignant hypertension)
- clinical relevant respiratory disease (GOLD IV)
- musculoskeletal disorders severely restricting the patients mobility (e.g. gonarthrosis, coxarthrosis)
- cirrhosis of the liver (Child B and C)
- Karnofsky performance status scale ≤ 60%
- maximal exercise capacity ≤ 50 watt
- clinically relevant lab factors (leukocyte count ≤ 3000/μl, thrombocyte count ≤ 20.000/μl, hemoglobin < 8 g/dl)
- physical activity level ≥ 18 MET-h/ week at screening
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Physical activity
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The patients will perform increasing volumes of moderate intensity endurance (e.g.
walking, cycling) exercise, leading up to 18 MET-hours per week by the end of three months.
Patients will then maintain this activity level for the remaining 9 months, with reduced supervision.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Target sample size
Tidsramme: one year
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The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year.
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one year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Physical activity
Tidsramme: at screening and 3, 6, 9, and 12 month after baseline
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Physical activity will be measured using physical activity diary, heart rate monitor (Sigma Sport PC 22.13), accelerometer (Aipermotion 440), and the German version of the International Physical Activity Questionnaire (IPAQ).
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at screening and 3, 6, 9, and 12 month after baseline
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Peak oxygen consumption
Tidsramme: at baseline and 12 month after baseline
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Spiroergometry will be used to assess peak oxygen consumption (VO2peak).
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at baseline and 12 month after baseline
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Patient satisfaction
Tidsramme: at 3, 6, 9, and 12 month after baseline
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Patient satisfaction will be measured using questionnaire.
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at 3, 6, 9, and 12 month after baseline
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Cancer related fatigue
Tidsramme: at screening and 6 and 12 month after baseline
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Fatigue will be measured using the German version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-FA13; reduced version with 13 items).
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at screening and 6 and 12 month after baseline
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Anxiety and depression
Tidsramme: at screening and 6 and 12 month after baseline
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Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D).
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at screening and 6 and 12 month after baseline
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Cancer related quality of life
Tidsramme: at screening and 6 and 12 month after baseline
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Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30).
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at screening and 6 and 12 month after baseline
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Quality of life in colorectal cancer
Tidsramme: at screening and 6 and 12 month after baseline
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Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire in colorectal cancer (EORTC QLQ-CR29).
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at screening and 6 and 12 month after baseline
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Adverse and serious adverse events
Tidsramme: one year
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Adverse (e.g.
dizziness, high blood pressure) and serious adverse events (e.g.
death, prolonged hospitalization) will be reported within 24 hours to the study physician via form.
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one year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Martin Halle, Prof. M.D., Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
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 (Faktiske)
1. januar 2014
Primær fullføring (Faktiske)
1. april 2015
Studiet fullført (Faktiske)
1. april 2015
Datoer for studieregistrering
Først innsendt
18. november 2013
Først innsendt som oppfylte QC-kriteriene
18. november 2013
Først lagt ut (Anslag)
25. november 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. november 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- F-PROTECT
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