Condition category
Cancer
Date applied
20/04/2014
Date assigned
30/04/2014
Last edited
02/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 body’s 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 measures

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

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

Sponsor information

Organisation

Yonsei University College of Medicine (South Korea)

Sponsor details

c/o Nam Kyu Kim
Department of Surgery
250 Seongsan-ro
Sedaemun-gu
Seoul
120-752
Korea
South

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes