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

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ClinicalTrials.gov Identifier: NCT03947840
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Umeå University

Study Description
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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

Study Design
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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, 2021
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Behavioral: Physical activity
    Se their physical activity level

Outcome Measures
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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

Eligibility Criteria
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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.
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03947840


Contacts
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Contact: Karin Strigård 0046907853583 ext 0046907853583 karin.strigard@umu.se
Contact: Niillas Blind 0046703210971 ext 0046907853583 niillas.blind@umu.se

Locations
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Sweden
Region Vasterbotten, centre of surgery Recruiting
Umeå, Vasterbotten, Sweden, 90185
Contact: Karin Strigård    0046907853583    karin.strigard@umu.se   
Contact: Niillas Blind    0046703210971    niillas.blind@umu.se   
Sponsors and Collaborators
Umeå University
Västerbotten County Council, Sweden
Investigators
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Principal Investigator: Karin Strigård Umeå Universitet
More Information
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03947840     History of Changes
Other Study ID Numbers: PACOS
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: May 2019
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
 Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases