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Physical Activity and Its Impact on Colon Cancer Surgery (PACOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03947840
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : December 1, 2020
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Umeå University

Brief Summary:

This is a prospective clinical study that studies how the physical activity level before operation of colon cancer affects the outcome of complication and histology.

The hypothesis is that patients who are more physical active have less postoperative complications and different histological immunological response around the tumor.

The investigators are testing the patients before the surgery with physical tests for fitness, strength and physical activity level. Questionnaires are also filled by the patients for pain, anxiety, depression and motivation for life style changes. Their body mass is analyzed with a DEXA (Dual-energy X-ray absorptiometry scan).

For one years the investigators are monitoring their activity and follow up for physical tests, DEXA and questionnaires is at 6 and 12 months.

The histology is analyzed after surgery to se if there is a different immunological response around the tumor.

Condition or disease Intervention/treatment
Colon Cancer Physical Activity Behavioral: Physical activity

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Physical Activity and Its Impact on Colon Cancer Surgery: Clinical and Histological Effects
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: Physical activity
    Se their physical activity level

Primary Outcome Measures :
  1. Number of postoperative complications [ Time Frame: 1 year ]
    To study if there are differences in postoperative complications in different active patients.

  2. Rate of immunological response [ Time Frame: 1 year ]
    To study if there is a difference in immunological reaction among physical active patients.

Secondary Outcome Measures :
  1. Rate of recovery in physical activity [ Time Frame: 1 year ]
    To study if physical active patients have a faster postoperative recovery

Biospecimen Retention:   Samples Without DNA
Histological samples from the tumor

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are going to surgery due to colon cancer.

Inclusion Criteria:

  • 18 years.
  • Colon cancer which is going to surgery

Exclusion Criteria:

  • Not able to do physical tests
  • Severe disease that makes a risk to do tests.
  • Not able to make informed consent due to psychic disease or dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03947840

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Contact: Karin Strigård 0046907853583 ext 0046907853583
Contact: Niillas Blind 0046703210971 ext 0046907853583

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Region Vasterbotten, centre of surgery Recruiting
Umeå, Vasterbotten, Sweden, 90185
Contact: Karin Strigård    0046907853583   
Contact: Niillas Blind    0046703210971   
Sponsors and Collaborators
Umeå University
Västerbotten County Council, Sweden
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Principal Investigator: Karin Strigård Umeå Universitet
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Responsible Party: Umeå University Identifier: NCT03947840    
Other Study ID Numbers: PACOS
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umeå University:
Colon cancer
Physical activity
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases