Clinical trial NCT03082495: Exercise During and After Neoadjuvant Rectal Cancer Treatment
Official title: A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Exercise
Cancer
Symptom management
Quality of life
presurgical
chemoradiotherapy
Physical Fitness
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2017-03-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Cardiorespiratory fitness
timeFrame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: pre-surgery (an average of 12 weeks)
measure: Functional fitness
timeFrame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
measure: Generic quality of life
timeFrame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
measure: Disease specific quality of life
timeFrame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
measure: Symptom burden
timeFrame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
measure: Exercise motivation
timeFrame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
measure: Eligibility rate
timeFrame: up to 20 months
measure: Recruitment rate
timeFrame: up to 20 months
measure: Exercise adherence rate
timeFrame: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
measure: Follow-up assessment rate
timeFrame: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
measure: Safety: Adverse event rate
timeFrame: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Other outcomes:
measure: Treatment toxicities
timeFrame: every week during NACRT (up to 6 weeks)
measure: Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date
timeFrame: post-NACRT (an average of 6 weeks)
measure: Number of patients receiving ≥ 80% of their planned chemotherapy dose
timeFrame: post-NACRT (an average of 6 weeks)
measure: Pathologic complete response rate
timeFrame: post-surgery (an average of 12 weeks)
measure: Length of hospital stay
timeFrame: post-surgery (an average of 12 weeks)
measure: Surgical approach
timeFrame: post-surgery (an average of 12 weeks)
measure: Ostomy
timeFrame: post-surgery (an average of 12 weeks)
measure: Sphincter preservation
timeFrame: post-surgery (an average of 12 weeks)
measure: Blood loss
timeFrame: post-surgery (an average of 12 weeks)
measure: Number of positive lymph nodes
timeFrame: post-surgery (an average of 12 weeks)
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Kerry S Courneya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.