Rectal Cancer
Conditions
Keywords
Exercise, Cancer, Symptom management, Quality of life, presurgical, chemoradiotherapy, Physical Fitness
Brief summary
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.
Interventions
BEHAVIORALExercise
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
Sponsors
Canadian Cancer Society (CCS)
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be blinded to group assignment for the clinical outcomes including treatment toxicity, treatment completion, treatment response, and surgical complications.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiorespiratory fitness | pre-NACRT (baseline), post-NACRT (an average of 6 weeks) | VO2 peak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional fitness | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | Senior's Fitness Test |
| Cardiorespiratory fitness | pre-surgery (an average of 12 weeks) | VO2 peak |
| Generic quality of life | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | European Organisation for Research and Treatment of Cancer core 30-item questionnaire |
| Disease specific quality of life | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer |
| Symptom burden | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | M.D. Anderson Symptom Inventory |
| Exercise motivation | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | Theory of planned behaviour |
| Eligibility rate | up to 20 months | Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT |
| Recruitment rate | up to 20 months | Number of patients randomized divided by the number of eligible patients |
| Exercise adherence rate | post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 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. |
| Follow-up assessment rate | post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 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. |
| Safety: Adverse event rate | post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | Number of serious adverse events that occur during exercise testing or the supervised exercise sessions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients receiving ≥ 80% of their planned chemotherapy dose | post-NACRT (an average of 6 weeks) | Obtained from electronic medical records |
| Pathologic complete response rate | post-surgery (an average of 12 weeks) | Obtained from electronic medical records |
| Length of hospital stay | post-surgery (an average of 12 weeks) | Obtained from electronic medical records |
| Surgical approach | post-surgery (an average of 12 weeks) | Obtained from electronic medical records |
| Ostomy | post-surgery (an average of 12 weeks) | Obtained from electronic medical records |
| Sphincter preservation | post-surgery (an average of 12 weeks) | Obtained from electronic medical records |
| Blood loss | post-surgery (an average of 12 weeks) | Obtained from electronic medical records |
| Number of positive lymph nodes | post-surgery (an average of 12 weeks) | Obtained from electronic medical records |
| Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date | post-NACRT (an average of 6 weeks) | Obtained from electronic medical records |
| Treatment toxicities | every week during NACRT (up to 6 weeks) | CTCAE Version 3.0 |
Countries
Canada
Outcome results
None listed