A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- University of Alberta
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in Cardiorespiratory fitness
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Cardiorespiratory fitness
Time Frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
VO2 peak
Secondary Outcomes
- 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))
- Exercise motivation(pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Eligibility rate(up to 20 months)
- Recruitment rate(up to 20 months)
- Exercise adherence rate(post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Follow-up assessment rate(post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Safety: Adverse event rate(post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))