Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy

NCT ID: NCT04749589

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-11

Study Completion Date

2023-05-31

Brief Summary

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The aim is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability.

Detailed Description

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Around 60% of newly diagnosed colorectal cancer patients suffer from iron deficiency at the time of diagnosis. The study hypothesis is that, besides leading to anemia, iron deficiency might be associated with impaired patient report outcomes in the domains of fatigue, quality of life, cognitive impairment and lower physical ability. No previous studies on colorectal cancer patients and iron deficiency are available.

The participants (patients suspected of colorectal cancer after endoscopy) will be tested on these parameters. The participants and the investigators are blinded to the patients iron status. The study takes place before any preoperative iron treatment. Multivariate analysis will be used taking into account, gender, age, hemoglobin, tumor stage.

Conditions

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Iron-deficiency Iron Deficiency Anemia Colorectal Cancer Fatigue Quality of Life Cognitive Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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iron deficient

ferritin\<30 or Transferine saturation\<.2

iron deficiency

Intervention Type DIAGNOSTIC_TEST

Its not an intervention. Its an observational study. The groups are defined based on their iron status

iron replete

opposite of the other group

iron deficiency

Intervention Type DIAGNOSTIC_TEST

Its not an intervention. Its an observational study. The groups are defined based on their iron status

Interventions

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iron deficiency

Its not an intervention. Its an observational study. The groups are defined based on their iron status

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients in whom endoscopy has raised suspicion of colorectal malignancy

Exclusion Criteria

* non fluent in Danish language
* cerebral impairment (ex severe dementia) so that informed consent can not be obtained
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torben Knudsen, ass. prof

Role: STUDY_DIRECTOR

Institute of regional health research, regional of southern denmark

Locations

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Sygehus Sønderjylland

Aabenraa, Region Syddanmark, Denmark

Site Status

Hospital of South West Jutland

Esbjerg, Region Syddanmark, Denmark

Site Status

Hospital of South West Jutland

Grindsted, Region Syddanmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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21 6250

Identifier Type: -

Identifier Source: org_study_id

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