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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03947840
Other study ID # PACOS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2019
Est. completion date February 20, 2024

Study information

Verified date February 2024
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date February 20, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical activity
Se their physical activity level

Locations

Country Name City State
Sweden Region Vasterbotten, centre of surgery Umeå Vasterbotten

Sponsors (2)

Lead Sponsor Collaborator
Umeå University Västerbotten County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of postoperative complications To study if there are differences in postoperative complications in different active patients. 1 year
Primary Rate of immunological response To study if there is a difference in immunological reaction among physical active patients. 1 year
Secondary Rate of recovery in physical activity To study if physical active patients have a faster postoperative recovery 1 year
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