Plain English Summary
Background and study aims
Cancer has become a major public health problem in South Korea. The lifestyle factors are important determinants of colorectal cancer risk. Previous studies have shown a strong association between the level of physical activity and the outcomes of colorectal cancer. However, the effects of exercise on insulin resistance and adipocytokines in colorectal cancer patients still need to be investigated. The aim of this study are to assess the effects of a 12-week home-based exercise intervention on insulin resistance and adiponectin (the hormone produced by fat cells which influences the bodys response to insulin) in colorectal cancer survivors.
Who can participate?
Patients with stage II-III colorectal cancer, who have completed all standard cancer treatment at least 4 weeks earlier but no more than 2 years.
What does the study involve?
Patients are randomly allocated to either the exercise group or the control group.
Exercise group patients will be encouraged to walk more than 10,000 steps per day. They will get exercise DVDs, will record their daily activities and will visit the clinic five times during the 12 weeks. Control group patients will be instructed to continue with their usual daily activities.
What are the possible benefits and risks or participating?
Participants allocated to the exercise group will receive the exercise DVDs, a pedometer, exercise hand outs, and results of clinical tests. There are no known risks to participants.
Where is the study run from?
Severance Hospital, Shinchon, Seoul (South Korea).
When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between August 2011 and December 2014.
Who is funding the study?
Ministry of Health and Welfare (South Korea)
Who is the main contact?
Professor Justin Jeon
jjeon@yonsei.ac.kr
Trial website
Contact information
Type
Scientific
Primary contact
Prof Justin Jeon
ORCID ID
Contact details
134 Shinchon-Dong
Seodaemun-Gu
Yonsei University
Seoul
120-749
Korea
South
jjeon@yonsei.ac.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of 12-week home-based exercise program on insulin resistance and adiponectin in colorectal cancer survivors: a randomized controlled trial
Acronym
Study hypothesis
The 12-week exercise intervention program will decrease fasting insulin resistance and increase adiponectin in colorectal cancer survivors.
Ethics approval
Institutional Ethics Review Board at Yonsei University College of Medicine
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stage II to III colorectal cancer survivors
Intervention
Participants will be randomized into either an exercise or usual care group via minimization method.
1. The exercise group will receive a 12-week home-based exercise program. They will be encouraged to walk more than 10,000 steps per day (pedometer will be provided). In addition, patients will be provided with exercise DVDs, which consisted of 30 minutes exercise using their own body weight, to be performed at home daily. Following each exercise session, participants will complete their exercise log, recording the daily steps, type of exercise and duration. Exercise group participants will visit the clinic three times during 6 weeks. They will have two exercise education sessions, and the exercise trainer will make sure that patients are able to perform the exercise properly.
2. Participants in the control group will be instructed to continue with their usual daily activities.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Level of fasting insulin will be measured by a chemiluminescence immunoassay
2. Adiponectin levels will be measured by an enzyme immunoassay kit
3. Insulin resistance will be estimated using the homeostatic model assessment of insulin resistance (HOMA-IR) index
Secondary outcome measures
1. hs-CRP will be measured by a latex-enhanced immunoturbidimetric assay using an ADNIA 1650 Chemistry system 2. TNF-a levels will be measured using a commercially available enzyme-linked immunosorbent assay
3. Chemerin levels will be measured by an enzyme immunoassay kit
4. Levels of fasting glucose, AST, ALT, GGT, TC, TG, HDL-C will be measured using an ADVIA 1650 Chemistry system
5. Physical fitness measured by the 30minute step test, 6-min walk test, chair stand and push up test
6. Quality of life measured by the FACT-C questionnaires
Overall trial start date
27/08/2011
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Between 18 and 75 years of age
2. Histologically confirmed stage II to III colorectal cancer
3. Completed surgery, radiotherapy, and/or chemotherapy within 4-104 weeks prior to the study
4. ECOG performance status of 0 of 1
5. Not planning extended absences in the 3 months subsequent to enrollment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
56 patients in each group
Participant exclusion criteria
1. Existing evidence of recurrent or metastatic disease
2. Participation in regular physical activity (purposeful activity of at least a moderate intensity of 200 minutes or more a week)
3. Pregnant or planned to be pregnant within 6 month
Recruitment start date
27/08/2011
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Korea, South
Trial participating centre
134 Shinchon-Dong, Seodaemun-Gu, Yonsei University
Seoul
120-749
Korea, South
Funders
Funder type
Government
Funder name
National Research Foundation of Korea (NRF) (No.2010-0009048)
Alternative name(s)
NRF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Korea, South
Funder name
Ministry of Health and Welfare - National R & D program for Cancer Control (Republic of Korea), Ref: 1120230
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list