- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01325909
Exercise Training in Colorectal Cancer Patients
Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.
The investigators wish to explore various hypotheses:
- Is exercise intervention feasible and tolerable in this cohort of patients?
- Can fitness be improved using a structured, responsive exercise training programme (SRETP)?
- Can SRETP improve quality of life?
- Can SRETP improve physical activity?
- Can SRETP improve surgical outcome?
- Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.
The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Liverpool, Storbritannien, L9 7AL
- Aintree University Hospitals
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- All patients listed to undergo elective colorectal cancer resection and longcourse neoadjuvant chemoradiotherapy at Aintree University Hospitals NHS Foundation Trust
Exclusion Criteria:
- Unable to consent
- Under 18 years of age
- Unable to perform exercise
- Meet any contraindications on the ATS CPET safety guidelines
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Övning
|
|
Inget ingripande: Ingen träning
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.
Tidsram: 3 years
|
3 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Other measures of physical fitness measured in CPET or the VO2 kinetics test
Tidsram: 3 years
|
3 years
|
Adherence to a 6 week interval exercise intervention.
Tidsram: 3 years
|
3 years
|
Optimal time for surgery indicating optimal oncological and physiological fitness
Tidsram: 3 years
|
3 years
|
Health related quality of life improvement as measured by SF36, EORCT c30 v3
Tidsram: 3 years
|
3 years
|
Outcome from major surgery measured by 5 day POMS
Tidsram: 3 years
|
3 years
|
Activity levels before during and after neoadjuvant chemoradiotherapy
Tidsram: 3 years
|
3 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Malcolm A West, MD MRCS, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
Publikationer och användbara länkar
Allmänna publikationer
- Loughney L, West MA, Dimitrov BD, Kemp GJ, Grocott MP, Jack S. Physical activity levels in locally advanced rectal cancer patients following neoadjuvant chemoradiotherapy and an exercise training programme before surgery: a pilot study. Perioper Med (Lond). 2017 Feb 16;6:3. doi: 10.1186/s13741-017-0058-3. eCollection 2017.
- Brunet J, Burke S, Grocott MP, West MA, Jack S. The effects of exercise on pain, fatigue, insomnia, and health perceptions in patients with operable advanced stage rectal cancer prior to surgery: a pilot trial. BMC Cancer. 2017 Feb 23;17(1):153. doi: 10.1186/s12885-017-3130-y.
- West MA, Dimitrov BD, Moyses HE, Kemp GJ, Loughney L, White D, Grocott MP, Jack S, Brown G. Timing of surgery following neoadjuvant chemoradiotherapy in locally advanced rectal cancer - A comparison of magnetic resonance imaging at two time points and histopathological responses. Eur J Surg Oncol. 2016 Sep;42(9):1350-8. doi: 10.1016/j.ejso.2016.04.003. Epub 2016 Apr 26.
- West MA, Loughney L, Lythgoe D, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. Effect of prehabilitation on objectively measured physical fitness after neoadjuvant treatment in preoperative rectal cancer patients: a blinded interventional pilot study. Br J Anaesth. 2015 Feb;114(2):244-51. doi: 10.1093/bja/aeu318. Epub 2014 Oct 1.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 11/H1002/12
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 .
Kliniska prövningar på Rektal cancer
-
King Faisal Specialist Hospital & Research CenterAvslutadEtt försök med preoperativ kemoradioterapi med capecitabin, strålning och cetuximab vid rektalcancerColon Rectal Cancer Duke Stage StagevalSaudiarabien
-
Institut BergoniéAvslutadMedium och Lower Rectal CancerFrankrike
-
Abramson Cancer Center of the University of PennsylvaniaAvslutadHuvud- och halscancer | Kolorektal cancer | Mag-tarmcancer | Biopsi bevisad icke småcellig lungcancer | Rectal cancer | Gynekologisk malignitet som kräver definitiv strålbehandlingFörenta staterna
-
University Health Network, TorontoAvslutad
-
Philips HealthcarePhilips Electronics Nederland B.V. acting through Philips CTO organizationAvslutadMalignt lymfom i lymfkörtlarna i inguinalregionen | Malignt lymfom av lymfkörtlar i axillären | Malignt lymfom i lymfkörtlar i livmoderhalsen | Karcinom i parotidkörteln | Colon Rectal Cancer Tubulovillous Adenocarcinoma | Tumör av mjukvävnad i huvud, ansikte och halsNederländerna
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AvslutadÅterkommande rektalkarcinom | Steg IIIA rektalcancer AJCC v7 | Steg IIIB rektalcancer AJCC v7 | Steg IIIC rektalcancer AJCC v7 | Rektalt mucinöst adenokarcinom | Rectal Signet Ring Cell Adenocarcinom | Steg IIA rektal cancer AJCC v7 | Steg IIB rektalcancer AJCC v7 | Steg IIC rektalcancer AJCC v7Förenta staterna
-
National Cancer Institute (NCI)AvslutadÅterkommande kolonkarcinom | Återkommande rektalkarcinom | Steg IVA tjocktarmscancer | Steg IVA ändtarmscancer | Steg IVB tjocktarmscancer | Steg IVB rektal cancer | Colon mucinöst adenokarcinom | Colon Signet Ring Cell Adenocarcinom | Rektalt mucinöst adenokarcinom | Rectal Signet Ring Cell AdenocarcinomFörenta staterna
-
Stanford UniversityAvslutadGastrointestinala neoplasmer | Bukspottskörtelcancer | Matstrupscancer | Anal cancer | Hepatobiliär neoplasma | Gastroesofageal cancer | Gallblåsa karcinom | Leverkarcinom | Cancer i gallblåsan | Gastrointestinal stromal tumör (GIST) | Carcinom i tjocktarmen | Magcancer | Gallgångskarcinom | Colon Rectal Cancer AdenocarcinomFörenta staterna
-
National Cancer Institute (NCI)AvslutadÅterkommande rektalkarcinom | Steg IIIA rektalcancer AJCC v7 | Steg IIIB rektalcancer AJCC v7 | Steg IIIC rektalcancer AJCC v7 | Steg IVA rektalcancer AJCC v7 | Steg IVB rektalcancer AJCC v7 | Rektalt mucinöst adenokarcinom | Rectal Signet Ring Cell Adenocarcinom | Steg IIA rektal cancer AJCC v7 | Steg IIB... och andra villkorFörenta staterna
-
National Cancer Institute (NCI)AvslutadSteg IIIA rektal cancer | Steg IIIB rektal cancer | Steg IIIC rektal cancer | Återkommande kolonkarcinom | Återkommande rektalkarcinom | Steg IIIA tjocktarmscancer | Steg IIIB Koloncancer | Steg IIIC tjocktarmscancer | Steg IVA tjocktarmscancer | Steg IVA ändtarmscancer | Steg IVB tjocktarmscancer | Steg IVB rektal... och andra villkorFörenta staterna