Exercise During and After Neoadjuvant Rectal Cancer Treatment
EXERT
A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
1 other identifier
interventional
36
1 country
1
Brief Summary
This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 17, 2017
CompletedStudy Start
First participant enrolled
June 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMay 27, 2022
March 1, 2022
2.3 years
February 9, 2017
May 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cardiorespiratory fitness
VO2 peak
pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
Secondary Outcomes (11)
Cardiorespiratory fitness
pre-surgery (an average of 12 weeks)
Functional fitness
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Generic quality of life
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Disease specific quality of life
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Symptom burden
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
- +6 more secondary outcomes
Other Outcomes (10)
Treatment toxicities
every week during NACRT (up to 6 weeks)
Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date
post-NACRT (an average of 6 weeks)
Number of patients receiving ≥ 80% of their planned chemotherapy dose
post-NACRT (an average of 6 weeks)
- +7 more other outcomes
Study Arms (2)
Exercise
EXPERIMENTALAerobic exercise
Usual Care
NO INTERVENTIONStandard medical care
Interventions
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
Eligibility Criteria
You may qualify if:
- All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Canadian Cancer Society (CCS)collaborator
Study Sites (1)
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Related Publications (4)
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.
PMID: 34158253BACKGROUNDMorielli 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. 2023 Aug;17(4):1171-1183. doi: 10.1007/s11764-021-01149-w. Epub 2021 Nov 29.
PMID: 34841461BACKGROUNDArthuso FZ, Morielli AR, Usmani N, Joseph K, Nijjar T, Tankel K, Fairchild A, Severin D, Boule NG, Courneya KS. Effects of Exercise on Motivational Outcomes in Rectal Cancer Patients During and After Neoadjuvant Chemoradiation: A Phase II Randomized Controlled Trial. Semin Oncol Nurs. 2023 Aug;39(4):151419. doi: 10.1016/j.soncn.2023.151419. Epub 2023 Apr 13.
PMID: 37061361DERIVEDMorielli 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.
PMID: 29329555DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerry S Courneya, PhD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor will be blinded to group assignment for the clinical outcomes including treatment toxicity, treatment completion, treatment response, and surgical complications.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2017
First Posted
March 17, 2017
Study Start
June 26, 2017
Primary Completion
October 17, 2019
Study Completion
September 1, 2020
Last Updated
May 27, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share