Exercise for Adults Diagnosed With Rectal Cancer

NCT ID: NCT03049124

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-12-04

Brief Summary

Currently, there is no clear indication if exercise is safe and if it confers health benefits for adults across the cancer trajectory (i.e., from diagnosis onward) for rectal cancer - a population who may have limited exercise tolerance and who may be at an increased risk for adverse events associated with exercise. In this prospective single-arm feasibility trial, we aim to examine the safety and feasibility of a 12-week exercise intervention for adults diagnosed with rectal cancer to inform the development of a large-scale randomized controlled trial that will assess the efficacy of exercise administered across the cancer trajectory for for rectal cancer. Adults who have been diagnosed with rectal cancer and are currently undergoing or have completed treatment (within the last five years) will be recruited over a 12-month period into a supervised exercise intervention consisting of aerobic and strength training to be done three times per week. Feasibility, safety, patient-reported outcomes, and physical tests will be performed pre-intervention and post-intervention. This study will provide data on the feasibility of an exercise intervention and will help determine if it is safe to progress with a large-scale randomized controlled trial to test the benefits of exercise for adults diagnosed with rectal cancer. It will also provide initial estimates of the parameters for patient-reported outcomes, which are required to calculate the sample size for the large-scale randomized controlled trial to ensure it is sufficiently powered.

The purpose of this prospective single-arm feasibility trial is to determine if a 12-week exercise intervention offered to adults diagnosed with rectal cancer surviviors is safe and feasible.

The specific objectives are to:

1. Test the feasibility and safety of a 12-week exercise intervention;

2. Obtain initial estimates of the parameters of the main outcomes to inform sample size calculations for the main study (i.e., means and standard deviations for patient-reported and physical outcomes);

3. Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise

Participants will be asked to complete a 12-week exercise intervention and all study assessments.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Participants will engage in supervised exercise 3 times per week for 60-75 minutes/session for 12 weeks. Sessions will include a warm-up (aerobic activity less than \< 60% of heart rate reserve), aerobic training (30 minutes of exercise at 60-75% of heart rate reserve, using cycle ergometers/treadmills), strength training (8 exercises; upper body, lower body, and core), and a cool-down (aerobic activity less than \< 60% of heart rate reserve) component.

Interventions

Exercise

Participants will engage in supervised exercise 3 times per week for 60-75 minutes/session for 12 weeks. Sessions will include a warm-up (aerobic activity less than \< 60% of heart rate reserve), aerobic training (30 minutes of exercise at 60-75% of heart rate reserve, using cycle ergometers/treadmills), strength training (8 exercises; upper body, lower body, and core), and a cool-down (aerobic activity less than \< 60% of heart rate reserve) component.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Men and women 18 to 85 years of age;

2. Diagnosed and/or completed treatment for stage I-III rectal cancer within the last 5 years;

3. Able to read/understand English or French;

4. Ambulatory;

5. Live <50km of the University of Ottawa;

6. Approval of healthcare provider to participate in the intervention.

Exclusion Criteria

1. Congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmia, myocardial infarction, major heart surgery, stroke, or pulmonary embolus;

2. A diagnosis of hypertension or a resting blood pressure of 160/90 mmHg or higher (i.e., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg);

3. The use of supplemental oxygen;

4. Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);

5. History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;

6. Hip fracture, hip or knee replacement in the past 6 months;

7. Impairments requiring mobility aids;

8. Stage V cancer;

9. Prior cancer diagnosis, excluding non-melanoma skin cancer;

10. Participating in another exercise trial;

11. Unwilling/unable to give informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ottawa

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Brunet

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Brunet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Locations

University of Ottawa

Ottawa, Ontario, Canada

Countries

Canada

References

Canadian Society for Exercise Physiology. Canadian Society for Exercise Physiology - Physical activity training for health. Ottawa, ON: Canadian Society for Exercise Physiology, 2013.

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Reference Type: BACKGROUND

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Brunet J, Price J, Delluc C. An exercise trial for adults undergoing neoadjuvant chemoradiotherapy for rectal cancer proves not feasible: recommendations for future trials. Trials. 2021 Jan 6;22(1):26. doi: 10.1186/s13063-020-04958-z.

Reference Type: DERIVED

PMID: 33407782 (View on PubMed)

Other Identifiers

RectalCaEx-JB-MV-KC

Identifier Type: -

Identifier Source: org_study_id