Clinical trial NCT03049124: Exercise for Adults Diagnosed With Rectal Cancer
Official title: Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rectal Cancer
Keywords: Exercise
Feasibility trial
Cancer
Chemoradiation
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion criteria are:

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 are:

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.

Of note, in addition to the exclusion criteria listed above, for individuals who are about to begin or are undergoing treatment healthcare providers will also employ clinical judgment concerning participant safety; that is, if the healthcare provider judges the patient to be at high risk for adverse events or medical complications if they participate in the intervention given their health status, they will not approach the patient to obtain permission for research personnel from the University of Ottawa to contact them.

Primary outcomes:
measure: Recruitment Rates
timeFrame: Through study completion, an average of 12 weeks
measure: Retention Rates
timeFrame: Through study completion, an average of 12 weeks
measure: Adherence Rates
timeFrame: Through study completion, an average of 12 weeks
measure: Number of Participants with Adverse Events
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
Other outcomes:
measure: Quality of Life: Functional Assessment of Cancer Therapy - Colorectal (Ward et al., 1999; Yost et al., 2005)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Cognitive Functioning: Functional Assessment of Cancer Therapy - Cognitive Function (Wagner et al., 2004)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Symptoms of Fatigue: the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (Yellen et al., 1997)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Resting Heart Rate: Heart Rate Monitor (Polar A300)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Blood Pressure: Blood Pressure Monitor (HealthSmart Digital Blood Pressure Monitor)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Body Mass Index: Tanita Scale (TBF-310 GS)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Aerobic Capacity: 6-Minute Walk Test (Canadian Society for Exercise Physiology, 2013; Irwin, 2012)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Musculoskeletal Strength: Combined Grip Strength Using a Handheld Dynamometer (Canadian Society for Exercise Physiology, 2013, 2013; Irwin, 2012)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Socio-Demographic and Medical Information Questionnaire
timeFrame: Baseline (week 0)
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Jennifer Brunet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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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citation: Irwin ML. ACSM's guide to exercise and cancer survivorship. Champaign, IL: American College of Sports Medicine, 2012.
citation: Wagner LI, Cella D, Sweet J, Forrestal S. (2004). Chemotherapy-related cognitive deficits: development of the FACT-Cog instrument. Ann Behav Med, 27, S10.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.