Colorectal Cancer Clinical Trial
Official title:
I-Walk-CRC - Feasibility and Efficacy of Interval Walking in Patients With Colorectal Cancer
Verified date | September 2017 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: The level physical exercise is strongly associated with colorectal cancer risk in
the general population, and recent data shows that physical activity after a colorectal
cancer diagnosis is inversely associated with mortality risk, indication the physical
exercise can protect against disease progression. However, few studies have successfully
performed exercise interventions in patients with colorectal cancer, and the potential
mechanisms responsible for the tumor suppressing effects of exercise remain poorly explored.
Purpose: To investigate interval-walking, delivered by the InterWalk smart phone application
as exercise-modality in patients with colorectal cancer. Specifically it is the aim to
explore if InterWalk is safe and feasible as well as effective to improve cardio-metabolic
health profile.
Subjects: Colorectal cancer patients, stage I-III, who are at least one month post-surgery
and have concluded any adjuvant chemotherapy treatment, are eligible for inclusion. Exclusion
criteria are: age <18; any major surgical procedure planned within 6 months after inclusion;
pregnancy; ongoing treatment for any known malignancy; performance status > 1; unable to read
and understand Danish
Methods: 40 colorectal cancer patients are included and randomized to I) InterWalk or II)
waiting list control for 24 weeks. Patients are evaluated at baseline, week 12 and week 24 by
assessment measures to determine cardio-metabolic health profile and other relevant study
outcomes, including: cardiopulmonary exercise test (VO2peak); anthropometrics; blood
pressure; resting heart rate; body composition; health related quality of life
questionnaires; plasma concentration levels of cholesterol, triglycerides, insulin, glucose
and inflammatory cytokines; insulin sensitivity; and cognitive function.
Status | Completed |
Enrollment | 39 |
Est. completion date | September 22, 2017 |
Est. primary completion date | September 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a verified stage I-III CRC diagnosis who has - All surgical and oncological treatments must be terminated Exclusion Criteria: - Any major surgical procedure planned within 6 months after inclusion - Pregnancy - Ongoing treatment for any known current malignancy - Performance status > 1 - Inability to read and understand Danish - Physically active for more than 150 minutes (moderate intensity) per week thus adhering to the current recommendations |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen | |
Denmark | Hvidovre Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in VO2peak | On a stationary bicycle, the participants perform 3 minutes warm up on 70 Watt followed by a step-by-step incremental test with workload increasing by 20 Watt every minute until exhaustion with direct measurement of oxygen uptake and carbon dioxide excretion with gas-exchange online-measurement equipment (Cosmed Quark, Rome, Italy). | Baseline to week 12 | |
Secondary | Change in Body composition | Body weight and anthropometrics (height, waist and hip circumference) will be assessed using standard procedures. Resting heart rate and blood pressure (Microlife, BPA100) will be determined in a supine position. Body composition (fat mass, bone mass and fat-free mass) and bone mineral density are analyzed by whole-body dual-energy X-ray absorptiometry (DXA) scan (Lunar, Lunar Corporation Madison, Wisconsin, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. Since the different chemical compounds in the body absorb the intensity of the X-rays differently, the scan allows for a valid determination of bone mass, fat mass and fat-free/bone-free mass | Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24 | |
Secondary | Changes in bloodbiochemistry from fasting blood samples | Patients will have a fasting blood (30ml EDTA) sample taken to determine fasting concentrations of cholesterol, triglycerides, inflammatory markers; HbA1C, leptin, adiponectin. | Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24 | |
Secondary | Changes in patient-reported Quality of Life | Patient reported outcomes include: Functional Assessment of Cancer Treatment (FACT)-C, International Physical Activity Questionnaires (I-PAQ), Pittsburgh Sleep Quality Index (PSQI) and Behavioral Exercise Regulations Questionnaire (BREC)-2. | Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24 | |
Secondary | Changes in insulin sensityvity by measure of Oral Glucose Tolerance Test (OGTT) | The patients undergo standard OGTT assessment, by drinking 75 g glucose mixed in 300 ml water and have 10 ml blood samples taken after 60 and 120 min for analyses of plasma glucose, insulin and C-peptide. | Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24 | |
Secondary | Change in VO2peak (secondary comparisons) | On a motorized treadmill, patients will perform a 5 min warm-up period on a walking speed corresponding to ~50% of the age-predicted HR-max. After a 3 min rest, the patients will perform a graded, walking VO2-peak with incremental inclination and speed every other minute (Technogym Runrace, Gambettola, Italy), using indirect calorimetry (CPET, Quark, Rom, Italy). | baseline-to-week24, week 12-to-week 24 |
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