Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Frailty

Rectal Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Herbal and Botanical

Vitamins

Cola

Patients receive multi-modal prehabilitation with exercise three times weekly, protein supplements, vitamin supplements, dietitian consultation and medical optimization prior to surgery. A minimum of four weeks.

A minimum of four weeks of prehabilitation with exercise three times a week, protein and vitamin supplements, dietitian consultation and medical optimization prior to surgery.

Prehabilitation

Rasmus D Bojesen, MD

Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery.

Fit for surgery is a randomized clinical trial of multimodal prehabilitation prior to colon or rectal cancer surgery. Participants will either receive

The study is a part of the PREHAB study which is performed in collaboration with international centers.

The full protocol are published BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

Randomized Clinical Trial with an intervention arm and a standard of care arm.

Due to the nature of the interventions neither participant, care provider or investigator is blinded. Outcome assessor of primary outcomes are blinded.

Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Fit for Surgery. Clinical Randomized Trial of Multimodal Prehabilitation Strategy in Patients With Colorectal Cancer.

Difference in postoperative recovery between baseline and within 3 days after surgery. The cumulative score ranges from 0-150, with a higher value indicating a better outcome

Changes in VO2 max between baseline and prior to surgery

Complications measured by the comprehensive complication index. The score ranges from 0-100 with with a higher value indicating a worse outcome.

Changes in immunological function measured by nanostring in blood and tumor (in the invasive front)

European Organisation for Research and Treatment of Cancer Questionaire c 30 (EORTC c30). The EORTC c30 contains 6 domains which will each be assessed for mean changes in their cumulative score. The domains are physical function, role function, emotional function, pain, fatigue and global health. A higher value indicating a worse outcome

European Organisation for Research and Treatment of Cancer Questionaire c 29 (EORTC). The questionnaire contains 29 items, with a 4 point Likert scale for symptoms and 7 point Likert scale for quality of life and global health. For the 4 point Likert scale the higher the score the worse the outcome. For the 7 point likert scale higher values indicating a better outcome. Analysis will be performed for changes in individual symptoms and cumulative aggregation of scores will not be performed.

Short Form 36 question (SF-36) health questionnaire. The questionnaire contains eight domains: physical functioning, pain, limitations due to physical health problems, limitations due to personal or emotional problems, emotional well-being, social functioning, fatigue, and general health perceptions. Scores for each domain range from 0 to 100 and the analysis will be performed as mean difference between baseline and the following time frame. A higher value indicating a better outcome.

Patient Health Questionnaire 9 (PHQ-9) Depression test. The PHQ-9 have a maximum of 27 points and a minimum of 0. The outcome is point change between baseline and following time frame. A higher value indicating a worse outcome

General Anxiety Disorder 7-item (GAD-7). The questionnaire have a maximum of 21 points and a minium of 0. The outcome is the point change between baselin and the following time frame. A higher value indicating a worse outcome

6-Minutes walk test. Measures how far the participant can walk in 6 minutes measured in meters

Sit-to-stand test. Test of how many times the patient can rise from a chair in 30 seconds.

Stair climb test will be measured as the number of steps (17 mc in height) the paitent can rise in 30 secounds.

Leg extension test will be measured by fixed dynaometer in newtons three times on each leg and the maximum for each leg used for analysis.

Hand grip strength measured by hand-held dynanometer in kilograms. Measured 3 times on each hand and will use the maximum obtained.

Increase/decrease in total body weight in percent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients	NCT04167436	Colon Cancer Rectal Cancer Frailty	Prehabilitation	18 Years -	Zealand University Hospital
Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients	NCT04167436	Colon Cancer Rectal Cancer Frailty	Prehabilitation	18 Years -	Zealand University Hospital

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