NCT03947840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

5.1 years

First QC Date

May 9, 2019

Last Update Submit

February 20, 2024

Conditions

Keywords

Colon cancerPhysical activity

Outcome Measures

Primary Outcomes (2)

  • Number of postoperative complications

    To study if there are differences in postoperative complications in different active patients.

    1 year

  • Rate of immunological response

    To study if there is a difference in immunological reaction among physical active patients.

    1 year

Secondary Outcomes (1)

  • Rate of recovery in physical activity

    1 year

Interventions

Se their physical activity level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are going to surgery due to colon cancer.

You may qualify if:

  • years.
  • Colon cancer which is going to surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Vasterbotten, centre of surgery

Umeå, Västerbotten County, 90185, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histological samples from the tumor

MeSH Terms

Conditions

Colonic NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karin Strigård

    Umeå Universitet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 13, 2019

Study Start

January 30, 2019

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations