Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT)

May 24, 2022 updated by: University of Alberta

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Aerobic exercise
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
No Intervention: Usual Care
Standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cardiorespiratory fitness
Time Frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
VO2 peak
pre-NACRT (baseline), post-NACRT (an average of 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness
Time Frame: pre-surgery (an average of 12 weeks)
VO2 peak
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)
Senior's Fitness Test
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)
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)
Disease specific quality of life
Time Frame: 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
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)
M.D. Anderson Symptom Inventory
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)
Theory of planned behaviour
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
Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT
up to 20 months
Recruitment rate
Time Frame: up to 20 months
Number of patients randomized divided by the number of eligible patients
up to 20 months
Exercise adherence rate
Time Frame: 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.
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)
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)
Safety: Adverse event rate
Time Frame: 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
post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment toxicities
Time Frame: every week during NACRT (up to 6 weeks)
CTCAE Version 3.0
every week during NACRT (up to 6 weeks)
Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date
Time Frame: post-NACRT (an average of 6 weeks)
Obtained from electronic medical records
post-NACRT (an average of 6 weeks)
Number of patients receiving ≥ 80% of their planned chemotherapy dose
Time Frame: post-NACRT (an average of 6 weeks)
Obtained from electronic medical records
post-NACRT (an average of 6 weeks)
Pathologic complete response rate
Time Frame: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Length of hospital stay
Time Frame: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Surgical approach
Time Frame: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Ostomy
Time Frame: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Sphincter preservation
Time Frame: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Blood loss
Time Frame: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Number of positive lymph nodes
Time Frame: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Canadian Cancer Society (CCS)

Investigators

  • Principal Investigator: Kerry S Courneya, PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Actual)

October 17, 2019

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREBA.CC-16-0986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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