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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iron deficient | ferritin<30 or Transferine saturation<.2 |
| |
| iron replete | opposite of the other group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iron deficiency | Diagnostic Test | Its not an intervention. Its an observational study. The groups are defined based on their iron status |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Fatigue sub-scale of Focussed assessment of cancer treatment - anemia | up to one months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | European Organisation for Research and Treatment of Cancer C30 | up to one months after inclusion |
| Cognitive ability | Montreal cognitive assessment |
| Measure | Description | Time Frame |
|---|---|---|
| post-operative run | the ability of the above mentioned test to predict the postoperative run (complications/length of stay) | 30-days postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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see inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Torben Knudsen, ass. prof | Institute of regional health research, regional of southern denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sygehus Sønderjylland | Aabenraa | Region Syddanmark | 6200 | Denmark | ||
| Hospital of South West Jutland |
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| up to one months after inclusion |
| endurance | 6 minutes walk test | up to one months after inclusion |
| peripheral muscular strengths | hand-held dynamometer | up to one months after inclusion |
| mobility and balance | timed-up-and-go-test | up to one months after inclusion |
| Esbjerg |
| Region Syddanmark |
| 6700 |
| Denmark |
| Hospital of South West Jutland | Grindsted | Region Syddanmark | 7200 | Denmark |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D015179 | Colorectal Neoplasms |
| D005221 | Fatigue |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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