Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT)
24. Mai 2022 aktualisiert von: University of Alberta
A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.
Studienübersicht
Detaillierte Beschreibung
The EXERT trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety.
Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision.
Participants will be randomly assigned to exercise training or usual care.
Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery.
Participants in the usual care group will be asked not to increase their exercise from baseline.
Assessments will be completed pre NACRT, post NACRT, and pre surgery.
The primary endpoint will be cardiorespiratory fitness (VO2 peak) at the post-NACRT time point assessed by a graded exercise test.
Secondary endpoints will include functional fitness, quality of life, and symptom management.
Exploratory clinical endpoints will include treatment toxicities, treatment completion, treatment response, and surgical complications.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
36
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision
Exclusion Criteria:
- Unable to consent
- Unable to perform aerobic exercise
- Intention to engage in a structured exercise program during NACRT and/or after NACRT and prior to surgery
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Übung
Aerobic Übung
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Supervised high-intensity interval training (HIIT) during NACRT followed by unsupervised moderate-to-vigorous intensity continuous exercise training after the completion of NACRT and before surgery
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Kein Eingriff: Usual Care
Standard medical care
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Cardiorespiratory fitness
Zeitfenster: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
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VO2 peak
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cardiorespiratory fitness
Zeitfenster: pre-surgery (an average of 12 weeks)
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VO2 peak
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pre-surgery (an average of 12 weeks)
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Functional fitness
Zeitfenster: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Senior's Fitness Test
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Generic quality of life
Zeitfenster: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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European Organisation for Research and Treatment of Cancer core 30-item questionnaire
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Disease specific quality of life
Zeitfenster: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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|
Symptom burden
Zeitfenster: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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M.D. Anderson Symptom Inventory
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Exercise motivation
Zeitfenster: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Theory of planned behaviour
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Eligibility rate
Zeitfenster: up to 20 months
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Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT
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up to 20 months
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Recruitment rate
Zeitfenster: up to 20 months
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Number of patients randomized divided by the number of eligible patients
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up to 20 months
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Exercise adherence rate
Zeitfenster: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Exercise adherence during NACRT will be assessed by the number of exercise sessions attended out of 18 as well as adherence to the intensity and duration of the HIT intervals.
Exercise adherence to the unsupervised exercise after NACRT will be assessed by self-report using the Godin Leisure-Time Exercise.
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Follow-up assessment rate
Zeitfenster: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Number of patients in each group completing the objective outcomes (cardiorespiratory fitness and functional fitness) and patient-reported outcomes (quality of life, symptom burden) at each timepoint.
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Safety: Adverse event rate
Zeitfenster: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Number of serious adverse events that occur during exercise testing or the supervised exercise sessions
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Treatment toxicities
Zeitfenster: every week during NACRT (up to 6 weeks)
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CTCAE Version 3.0
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every week during NACRT (up to 6 weeks)
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Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date
Zeitfenster: post-NACRT (an average of 6 weeks)
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Obtained from electronic medical records
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post-NACRT (an average of 6 weeks)
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Number of patients receiving ≥ 80% of their planned chemotherapy dose
Zeitfenster: post-NACRT (an average of 6 weeks)
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Obtained from electronic medical records
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post-NACRT (an average of 6 weeks)
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Pathologic complete response rate
Zeitfenster: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Length of hospital stay
Zeitfenster: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Surgical approach
Zeitfenster: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Ostomy
Zeitfenster: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Sphincter preservation
Zeitfenster: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Blood loss
Zeitfenster: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Number of positive lymph nodes
Zeitfenster: post-surgery (an average of 12 weeks)
|
Obtained from electronic medical records
|
post-surgery (an average of 12 weeks)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kerry S Courneya, PhD, University of Alberta
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Joseph K, Nijjar T, Fairchild A, Courneya KS. Feasibility, Safety, and Preliminary Efficacy of Exercise During and After Neoadjuvant Rectal Cancer Treatment: A Phase II Randomized Controlled Trial. Clin Colorectal Cancer. 2021 Sep;20(3):216-226. doi: 10.1016/j.clcc.2021.05.004. Epub 2021 May 26.
- Morielli AR, Boule NG, Usmani N, Tankel K, Joseph K, Severin D, Fairchild A, Nijjar T, Courneya KS. Effects of exercise during and after neoadjuvant chemoradiation on symptom burden and quality of life in rectal cancer patients: a phase II randomized controlled trial. J Cancer Surviv. 2021 Nov 29. doi: 10.1007/s11764-021-01149-w. Online ahead of print.
- Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Nijjar T, Joseph K, Fairchild A, Courneya KS. Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial. Trials. 2018 Jan 12;19(1):35. doi: 10.1186/s13063-017-2398-1.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
26. Juni 2017
Primärer Abschluss (Tatsächlich)
17. Oktober 2019
Studienabschluss (Tatsächlich)
1. September 2020
Studienanmeldedaten
Zuerst eingereicht
9. Februar 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. März 2017
Zuerst gepostet (Tatsächlich)
17. März 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Mai 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Mai 2022
Zuletzt verifiziert
1. März 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HREBA.CC-16-0986
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