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Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT)

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ClinicalTrials.gov Identifier: NCT03082495
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

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

Rectal cancer patients will be randomly assigned to aerobic exercise or usual care. Patients in the aerobic exercise group will be asked to complete 3 supervised high-intensity aerobic interval training (HIT) session/week during NACRT and ≥ 150 minutes/week of unsupervised aerobic exercise after NACRT.

Primary hypothesis: aerobic exercise during and after NACRT, compare to usual care, will result in significantly better cardiorespiratory fitness.


Condition or disease Intervention/treatment Phase
Rectal Cancer Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will be blinded to group assignment for the clinical outcomes including treatment toxicity, treatment completion, treatment response, and surgical complications.
Primary Purpose: Supportive Care
Official Title: A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
Aerobic exercise
Behavioral: Exercise
Supervised high-intensity aerobic interval training (HIT) during NACRT followed by unsupervised moderate-to-high intensity aerobic exercise after the completion of NACRT and before surgery

No Intervention: Usual Care
Standard medical care



Primary Outcome Measures :
  1. Change in Cardiorespiratory fitness [ Time Frame: pre-NACRT (baseline), post-NACRT (an average of 6 weeks) ]
    VO2 peak


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082495


Contacts
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Contact: Andria Morielli, MSc 780-492-2829 morielli@ualberta.ca

Locations
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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Andria Morielli, MSc         
Sponsors and Collaborators
University of Alberta
Canadian Cancer Society Research Institute (CCSRI)
Investigators
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Principal Investigator: Kerry S Courneya, PhD University of Alberta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03082495     History of Changes
Other Study ID Numbers: HREBA.CC-16-0986
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Exercise
Cancer
Symptom management
Quality of life
presurgical
chemoradiotherapy
Physical Fitness
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases