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

Modulex

Status: Completed

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

Treatments: Diagnostic Test: iron deficiency

Study type: Observational

Funder types: Other

Identifiers

NCT04749589

21 6250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

iron deficient

Description:

ferritin\<30 or Transferine saturation\<.2

Treatment:

Diagnostic Test: iron deficiency

iron replete

Description:

opposite of the other group

Treatment:

Diagnostic Test: iron deficiency