Rectal CancerEXERTNCT03082495
Exercise During and After Neoadjuvant Rectal Cancer Treatment
A study testing Exercise in people with Rectal Cancer, run by University of Alberta at 1 site in Canada.
Trial summary
This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jun 2017to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Rectal Cancer
- Being tested
- Exercise
- Keywords
- Exercise, Cancer, Symptom management, Quality of life, presurgical, chemoradiotherapy, Physical Fitness
- Medical subject headings
- Rectal Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Aerobic exercise Receives: Behavioral: Exercise |
| Usual Care | No intervention | Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiorespiratory fitness
VO2 peak
Measured: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
Secondary outcomes (11)
Cardiorespiratory fitness
VO2 peak
Measured: pre-surgery (an average of 12 weeks)
Functional fitness
Senior's Fitness Test
Measured: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Generic quality of life
European Organisation for Research and Treatment of Cancer core 30-item questionnaire
Measured: 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
Measured: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Symptom burden
M.D. Anderson Symptom Inventory
Measured: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Exercise motivation
Theory of planned behaviour
Measured: 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
Measured: up to 20 months
Recruitment rate
Number of patients randomized divided by the number of eligible patients
Measured: 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.
Measured: 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.
Measured: 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
Measured: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start26 Jun 2017
- Primary completion17 Oct 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- Kerry S Courneya, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082495
- Sponsor's protocol ID
- HREBA.CC-16-0986
- Acronym
- EXERT
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2017
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34158253Morielli 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.
PubMed 34841461Arthuso 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.
PubMed 37061361Morielli 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.
PubMed 29329555
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT03082495
- Acronym / sponsor ID
- EXERT / HREBA.CC-16-0986
- Conditions
- Rectal Cancer
- Keywords
- Exercise, Cancer, Symptom management, Quality of life, presurgical, chemoradiotherapy, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseAerobic exercise |
| Usual Care | No intervention | –Standard medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSupervised 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 | Behavioural | Exercise |
Primary outcome
Change in Cardiorespiratory fitness
Time frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
VO2 peak
11 secondary outcomes
Cardiorespiratory fitness
Time frame: pre-surgery (an average of 12 weeks)
Functional fitness
Time frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Generic quality of life
Time frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Disease specific quality of life
Time frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Symptom burden
Time frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Exercise motivation
Time frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Eligibility rate
Time frame: up to 20 months
Recruitment rate
Time frame: up to 20 months
Exercise adherence rate
Time frame: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Follow-up assessment rate
Time frame: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Safety: Adverse event rate
Time frame: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 34158253Morielli 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.
- Background: PubMed 34841461Morielli 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.
- Derived from this study: PubMed 37061361Arthuso 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.
- Derived from this study: PubMed 29329555Morielli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry S Courneya, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Rectal Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiorespiratory fitness (time frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082495, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.