Exercise for Adults Diagnosed With Rectal Cancer

NCT03049124 | Withdrawn

• 1 other identifier: RectalCaEx-JB-MV-KC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 1.Test the feasibility and safety of a 12-week exercise intervention;
2. 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. 3.Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

Conditions

Rectal Cancer

Keywords

Exercise; Feasibility trial; Cancer; Chemoradiation

Outcome Measures

Primary Outcomes (4)

• Recruitment Rates

  The number of eligible participants who enrol in the study out of the number who are referred.

  Through study completion, an average of 12 weeks

• Retention Rates

  The number of participants completing the intervention and all scheduled assessments.

  Through study completion, an average of 12 weeks

• Adherence Rates

  The number of exercise sessions completed out of 36.

  Through study completion, an average of 12 weeks

• Number of Participants with Adverse Events

  The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the exercise sessions and/or its assessments.

  Through study completion, an average of 12 weeks

Other Outcomes (11)

• Quality of Life: Functional Assessment of Cancer Therapy - Colorectal (Ward et al., 1999; Yost et al., 2005)

  Baseline (week 0) and post-intervention (week 12)

• Cognitive Functioning: Functional Assessment of Cancer Therapy - Cognitive Function (Wagner et al., 2004)

  Baseline (week 0) and post-intervention (week 12)

• Symptoms of Fatigue: the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (Yellen et al., 1997)

  Baseline (week 0) and post-intervention (week 12)

Study Arms (1)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Interventions

Exercise 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.

Exercise

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18 to 85 years of age;
• Diagnosed and/or completed treatment for stage I-III rectal cancer within the last 5 years;
• Able to read/understand English or French;
• Ambulatory;
• Live \<50km of the University of Ottawa;
• Approval of healthcare provider to participate in the intervention.

You may not qualify if:

• 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;
• 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);
• The use of supplemental oxygen;
• Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);
• History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;
• Hip fracture, hip or knee replacement in the past 6 months;
• Impairments requiring mobility aids;
• Stage V cancer;
• Prior cancer diagnosis, excluding non-melanoma skin cancer;
• Participating in another exercise trial;
• Unwilling/unable to give informed consent.

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (9)

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

  BACKGROUND

• Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

  PMID: 4053261 BACKGROUND

• Irwin ML. ACSM's guide to exercise and cancer survivorship. Champaign, IL: American College of Sports Medicine, 2012.

  BACKGROUND

• Wagner LI, Cella D, Sweet J, Forrestal S. (2004). Chemotherapy-related cognitive deficits: development of the FACT-Cog instrument. Ann Behav Med, 27, S10.

  BACKGROUND

• Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999 May;8(3):181-95. doi: 10.1023/a:1008821826499.

  PMID: 10472150 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.

  PMID: 9095563 BACKGROUND

• Yost KJ, Cella D, Chawla A, Holmgren E, Eton DT, Ayanian JZ, West DW. Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J Clin Epidemiol. 2005 Dec;58(12):1241-51. doi: 10.1016/j.jclinepi.2005.07.008. Epub 2005 Oct 13.

  PMID: 16291468 BACKGROUND

• 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.

  PMID: 33407782 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer Brunet, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: November 1, 2017
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)