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Completed

NCT Number: NCT04749589

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

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Cognition Disorders Cognitive Dysfunction Cognitive Impairment Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Fatigue Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Mental Disorders Metabolic Diseases Neoplasms Neoplasms by Site Neurocognitive Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Quality of Life Rectal Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sygehus Sønderjylland, Aabenraa, Region Syddanmark, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron deficiency

Diagnostic Test

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

Primary outcomes

  1. Fatigue

    Time frame: up to one months after inclusion

    Fatigue sub-scale of Focussed assessment of cancer treatment - anemia

Secondary outcomes

  1. Quality of life

    Time frame: up to one months after inclusion

    European Organisation for Research and Treatment of Cancer C30

  2. Cognitive ability

    Time frame: up to one months after inclusion

    Montreal cognitive assessment

  3. endurance

    Time frame: up to one months after inclusion

    6 minutes walk test

  4. peripheral muscular strengths

    Time frame: up to one months after inclusion

    hand-held dynamometer

  5. mobility and balance

    Time frame: up to one months after inclusion

    timed-up-and-go-test

Other outcomes

  1. post-operative run

    Time frame: 30-days postoperatively

    the ability of the above mentioned test to predict the postoperative run (complications/length of stay)

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2021
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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