Exercise During and After Neoadjuvant Rectal Cancer Treatment

Rectal Cancer Clinical Trial

— EXERT  

Official title:

A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082495
• Other study ID #: HREBA.CC-16-0986
• Status: Completed
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 1, 2020
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Behavioral:
• Exercise
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

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Cancer Society (CCS)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Morielli AR, Boulé 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. 2021 Nov 29. doi: 10.1007/s11764-021-01149-w. [Epub ahead of print] — View Citation

Morielli AR, Usmani N, Boulé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment toxicities	CTCAE Version 3.0	every week during NACRT (up to 6 weeks)
Other	Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date	Obtained from electronic medical records	post-NACRT (an average of 6 weeks)
Other	Number of patients receiving = 80% of their planned chemotherapy dose	Obtained from electronic medical records	post-NACRT (an average of 6 weeks)
Other	Pathologic complete response rate	Obtained from electronic medical records	post-surgery (an average of 12 weeks)
Other	Length of hospital stay	Obtained from electronic medical records	post-surgery (an average of 12 weeks)
Other	Surgical approach	Obtained from electronic medical records	post-surgery (an average of 12 weeks)
Other	Ostomy	Obtained from electronic medical records	post-surgery (an average of 12 weeks)
Other	Sphincter preservation	Obtained from electronic medical records	post-surgery (an average of 12 weeks)
Other	Blood loss	Obtained from electronic medical records	post-surgery (an average of 12 weeks)
Other	Number of positive lymph nodes	Obtained from electronic medical records	post-surgery (an average of 12 weeks)
Primary	Change in Cardiorespiratory fitness	VO2 peak	pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
Secondary	Cardiorespiratory fitness	VO2 peak	pre-surgery (an average of 12 weeks)
Secondary	Functional fitness	Senior's Fitness Test	pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary	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)
Secondary	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)
Secondary	Symptom burden	M.D. Anderson Symptom Inventory	pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary	Exercise motivation	Theory of planned behaviour	pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Secondary	Eligibility rate	Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT	up to 20 months
Secondary	Recruitment rate	Number of patients randomized divided by the number of eligible patients	up to 20 months
Secondary	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)
Secondary	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)
Secondary	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)