Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Tertiary Prevention by Exercise in Colorectal Cancer Therapy (F-PROTECT)

24. november 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyskland
      • Munich, Tyskland, 80809
        • Department of Medicine, Division of Prevention and Sports Medicine TU Munich

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

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Physical activity
Adfærdsmæssigt: Physical activity
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Target sample size
Tidsramme: one year
The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year.
one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity
Tidsramme: at screening and 3, 6, 9, and 12 month after baseline
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).
at screening and 3, 6, 9, and 12 month after baseline
Peak oxygen consumption
Tidsramme: at baseline and 12 month after baseline
Spiroergometry will be used to assess peak oxygen consumption (VO2peak).
at baseline and 12 month after baseline
Patient satisfaction
Tidsramme: at 3, 6, 9, and 12 month after baseline
Patient satisfaction will be measured using questionnaire.
at 3, 6, 9, and 12 month after baseline
Cancer related fatigue
Tidsramme: at screening and 6 and 12 month after baseline
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).
at screening and 6 and 12 month after baseline
Anxiety and depression
Tidsramme: at screening and 6 and 12 month after baseline
Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D).
at screening and 6 and 12 month after baseline
Cancer related quality of life
Tidsramme: at screening and 6 and 12 month after baseline
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).
at screening and 6 and 12 month after baseline
Quality of life in colorectal cancer
Tidsramme: at screening and 6 and 12 month after baseline
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).
at screening and 6 and 12 month after baseline
Adverse and serious adverse events
Tidsramme: one year
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.
one year

Samarbejdspartnere og efterforskere

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

Sponsor

Technical University of Munich

Samarbejdspartnere

German Cancer Aid

Efterforskere

  • Ledende efterforsker: Martin Halle, Prof. M.D., Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich

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 (Faktiske)

1. januar 2014

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

18. november 2013

Først indsendt, der opfyldte QC-kriterier

18. november 2013

Først opslået (Skøn)

25. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • F-PROTECT

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 .

Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med Physical activity

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner