Tertiary Prevention by Exercise in Colorectal Cancer Therapy (F-PROTECT)
24 november 2017 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Inte tillämpbar
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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Munich, Tyskland, 80809
- Department of Medicine, Division of Prevention and Sports Medicine TU Munich
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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
40 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Target sample size
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Physical activity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Martin Halle, Prof. M.D., Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
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 (Faktisk)
1 januari 2014
Primärt slutförande (Faktisk)
1 april 2015
Avslutad studie (Faktisk)
1 april 2015
Studieregistreringsdatum
Först inskickad
18 november 2013
Först inskickad som uppfyllde QC-kriterierna
18 november 2013
Första postat (Uppskatta)
25 november 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 november 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 november 2017
Senast verifierad
1 november 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- F-PROTECT
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .