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| Name | Class |
|---|---|
| Canadian Cancer Society (CCS) | OTHER |
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This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Aerobic exercise |
|
| Usual Care | No Intervention | Standard medical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiorespiratory fitness | VO2 peak | pre-NACRT (baseline), post-NACRT (an average of 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | VO2 peak | pre-surgery (an average of 12 weeks) |
| Functional fitness | Senior's Fitness Test | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment toxicities | CTCAE Version 3.0 | 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 | Obtained from electronic medical records |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry S Courneya, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34158253 | Background | 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. | |
| 34841461 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The outcome assessor will be blinded to group assignment for the clinical outcomes including treatment toxicity, treatment completion, treatment response, and surgical complications.
| 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) |
| 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) |
| Symptom burden | M.D. Anderson Symptom Inventory | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) |
| Exercise motivation | Theory of planned behaviour | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) |
| Eligibility rate | Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT | up to 20 months |
| Recruitment rate | Number of patients randomized divided by the number of eligible patients | up to 20 months |
| 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) |
| 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) |
| 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) |
| post-NACRT (an average of 6 weeks) |
| Number of patients receiving ≥ 80% of their planned chemotherapy dose | Obtained from electronic medical records | post-NACRT (an average of 6 weeks) |
| Pathologic complete response rate | Obtained from electronic medical records | post-surgery (an average of 12 weeks) |
| Length of hospital stay | Obtained from electronic medical records | post-surgery (an average of 12 weeks) |
| Surgical approach | Obtained from electronic medical records | post-surgery (an average of 12 weeks) |
| Ostomy | Obtained from electronic medical records | post-surgery (an average of 12 weeks) |
| Sphincter preservation | Obtained from electronic medical records | post-surgery (an average of 12 weeks) |
| Blood loss | Obtained from electronic medical records | post-surgery (an average of 12 weeks) |
| Number of positive lymph nodes | Obtained from electronic medical records | post-surgery (an average of 12 weeks) |
| 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. 2023 Aug;17(4):1171-1183. doi: 10.1007/s11764-021-01149-w. Epub 2021 Nov 29. |
| 37061361 | Derived | Arthuso 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. |
| 29329555 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |