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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03082495
Other study ID # HREBA.CC-16-0986
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 26, 2017
Est. completion date September 1, 2020

Study information

Verified date March 2022
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 1, 2020
Est. primary completion date October 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
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

Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Alberta Canadian Cancer Society (CCS)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Morielli AR, Boulé 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. [Epub ahead of print] — View Citation

Morielli AR, Usmani N, Boulé 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Treatment toxicities CTCAE Version 3.0 every week during NACRT (up to 6 weeks)
Other Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date Obtained from electronic medical records post-NACRT (an average of 6 weeks)
Other Number of patients receiving = 80% of their planned chemotherapy dose Obtained from electronic medical records post-NACRT (an average of 6 weeks)
Other Pathologic complete response rate Obtained from electronic medical records post-surgery (an average of 12 weeks)
Other Length of hospital stay Obtained from electronic medical records post-surgery (an average of 12 weeks)
Other Surgical approach Obtained from electronic medical records post-surgery (an average of 12 weeks)
Other Ostomy Obtained from electronic medical records post-surgery (an average of 12 weeks)
Other Sphincter preservation Obtained from electronic medical records post-surgery (an average of 12 weeks)
Other Blood loss Obtained from electronic medical records post-surgery (an average of 12 weeks)
Other Number of positive lymph nodes Obtained from electronic medical records post-surgery (an average of 12 weeks)
Primary Change in Cardiorespiratory fitness VO2 peak pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
Secondary Cardiorespiratory fitness VO2 peak pre-surgery (an average of 12 weeks)
Secondary Functional fitness Senior's Fitness Test pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary Generic quality of life European Organisation for Research and Treatment of Cancer core 30-item questionnaire pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary Disease specific quality of life European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary Symptom burden M.D. Anderson Symptom Inventory pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary Exercise motivation Theory of planned behaviour pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary Eligibility rate Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT up to 20 months
Secondary Recruitment rate Number of patients randomized divided by the number of eligible patients up to 20 months
Secondary Exercise adherence rate 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. post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary Follow-up assessment rate 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. post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary Safety: Adverse event rate Number of serious adverse events that occur during exercise testing or the supervised exercise sessions post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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