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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04749589
Enrollment
200
Registered
2021-02-11
Start date
2021-02-11
Completion date
2023-05-31
Last updated
2023-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTiron deficiency

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

Sponsors

Esbjerg Hospital - University Hospital of Southern Denmark
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fatigueup to one months after inclusionFatigue sub-scale of Focussed assessment of cancer treatment - anemia

Secondary

MeasureTime frameDescription
Quality of lifeup to one months after inclusionEuropean Organisation for Research and Treatment of Cancer C30
Cognitive abilityup to one months after inclusionMontreal cognitive assessment
peripheral muscular strengthsup to one months after inclusionhand-held dynamometer
mobility and balanceup to one months after inclusiontimed-up-and-go-test
enduranceup to one months after inclusion6 minutes walk test

Other

MeasureTime frameDescription
post-operative run30-days postoperativelythe ability of the above mentioned test to predict the postoperative run (complications/length of stay)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026