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The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.
All patients with colon cancer who are intended for curative surgery without neoadjuvant chemotherapy who are >=60 years old will be screened with an ergospirometry. The ones that have a ventilate anaerobic threshold (VAT) of less than 11 mg/ml/kg will be included in the study as they are considered extra frail and have a previously proven high risk for complications. These patients will be randomized to standard care or an intervention of prehabilitation consisting of immunonutrition (protein supplement, multivitamin supplement, Selene etc) and an exercise regimen with 4x1 hours per week of cycling on an ergometer. The exercise regimen will be performed in a group of patients and will be led by a physical therapist to ensure compliance. The resistance of the ergometer will be standardized according to the patient's VAT.
The primary outcome measures will be number of and severity of postoperative complications. Secondary outcome measures include quality of life during prehabilitation with repeated measurements during 5 years after surgery, disease-free survival and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Arm | Active Comparator | Standard perioperative care is given. |
|
| Interventional Arm | Experimental | Intervention of prehabilitation and immunonutrition is given prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation and Immunonutrition | Other | See study synopsis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Severity of postoperative complications according do Clavien-Dindo | Assessed when patient is discharged from hospital |
| Complications | Number of complication(s) according to POMS | Assessed at postoperative day 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life with SF-36 | Quality of life | At point in time when patient is informed of the cancer, after prehabilitation (just before surgery), 30 days, 2, 3 and 6 months, 1, 3 and 5 years after surgery. |
| Disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Öberg, MD, PhD | Contact | +46424061000 | stefan.oberg@med.lu.se |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Öberg, MD, PhD | Region Skåne/Lund University | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2019 | Dec 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Randomized two-armed clinical trial
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| Standard Care Arm |
| Other |
Standard care as per the daily routines of the Hospital at which the study takes place |
|
Cancer-free survival Cancer-free survival of the group of the group
| 30 and 90 days after surgery, 1, 3 and 5 years after surgery. |
| Overall survival | Overall survival of the group (taking all causes of death into account) | 30 and 90 days after surgery, 1, 3 and 5 years after surgery. |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |