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- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Liverpool, Royaume-Uni, L9 7AL
- Aintree University Hospitals
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Exercer
|
|
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Aucune intervention: Pas d'exercice
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.
Délai: 3 years
|
3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Other measures of physical fitness measured in CPET or the VO2 kinetics test
Délai: 3 years
|
3 years
|
|
Adherence to a 6 week interval exercise intervention.
Délai: 3 years
|
3 years
|
|
Optimal time for surgery indicating optimal oncological and physiological fitness
Délai: 3 years
|
3 years
|
|
Health related quality of life improvement as measured by SF36, EORCT c30 v3
Délai: 3 years
|
3 years
|
|
Outcome from major surgery measured by 5 day POMS
Délai: 3 years
|
3 years
|
|
Activity levels before during and after neoadjuvant chemoradiotherapy
Délai: 3 years
|
3 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Malcolm A West, MD MRCS, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 11/H1002/12
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