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Completed

NCT Number: NCT03082495

Exercise During and After Neoadjuvant Rectal Cancer Treatment

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

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Key information

Conditions

Rectal Cancer Behavior Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. Change in Cardiorespiratory fitness

    Time frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)

    VO2 peak

Secondary outcomes

  1. Cardiorespiratory fitness

    Time frame: pre-surgery (an average of 12 weeks)

    VO2 peak

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Recruitment rate

    Time frame: up to 20 months

    Number of patients randomized divided by the number of eligible patients

  9. 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.

  10. 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.

  11. 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

Other outcomes

  1. Treatment toxicities

    Time frame: every week during NACRT (up to 6 weeks)

    CTCAE Version 3.0

  2. 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

  3. Number of patients receiving ≥ 80% of their planned chemotherapy dose

    Time frame: post-NACRT (an average of 6 weeks)

    Obtained from electronic medical records

  4. Pathologic complete response rate

    Time frame: post-surgery (an average of 12 weeks)

    Obtained from electronic medical records

  5. Length of hospital stay

    Time frame: post-surgery (an average of 12 weeks)

    Obtained from electronic medical records

  6. Surgical approach

    Time frame: post-surgery (an average of 12 weeks)

    Obtained from electronic medical records

  7. Ostomy

    Time frame: post-surgery (an average of 12 weeks)

    Obtained from electronic medical records

  8. Sphincter preservation

    Time frame: post-surgery (an average of 12 weeks)

    Obtained from electronic medical records

  9. Blood loss

    Time frame: post-surgery (an average of 12 weeks)

    Obtained from electronic medical records

  10. Number of positive lymph nodes

    Time frame: post-surgery (an average of 12 weeks)

    Obtained from electronic medical records

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

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

Acronym: EXERT

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 17, 2017
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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