Effect of Prehabilitation on the Lean Mass Index (IMM) in ERAS PROGRAMM.

Study Overview
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Brief Summary
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The implementation of prehabilitation in patients operated on for colon cancer in a multimodal rehabilitation regimen improves the values of the lean body mass or lean mass index, positively influencing the results of clinical, analytical and radiological nutritional values pre- and postoperatively and in morbi-mortality, recovery, average stay and re-entry rates.

Official Title
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Effect of Prehabilitation on the Lean Mass Index (IMM) in Patients Operated on for Colon Cancer in ERAS Programm.

Conditions
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Colo-rectal Cancer, Nutrition Disorders

Intervention / Treatment
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* Other: Prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: It is considered that the subject suffers a confirmed diagnosis of colon cancer and is going to undergo surgery on a scheduled basis under a RHMM program. The subject is ≥ 18 years of age. The subject can perform any of the two proposed treatments. Preoperative staging TxNxM0. The patient has voluntarily signed and dated an informed consent document (IC), approved by an independent Ethics Committee (CEIC) before participating in the study. Exclusion Criteria: Patients with rectal cancer. The study doctor determines that the subject is not eligible to participate. The subject can not give informed consent to participate in the study. The subject can not perform the pre-habilitation. Non-acceptance or impossibility of following rehabilitation protocol multimodal The subject was previously scheduled at the time of the inclusion of the nutritional supplement study, whether it is different or the same that would be scheduled at this time Subjects who have received previous radiochemotherapy, HIV, gestational stage, psychiatric, with CRF who are undergoing renal replacement techniques, urgent surgery, with intestinal obstructions, with uncontrolled infections, urgent surgery, distant metastasis, ASA IV, advanced liver failure, severe coagulation disorder, severe hyperlipidemia and hyperglycemia or difficult to control. Subject has renal or hepatic impairment (GFR <60ml / m or AST / ALT 3 x upper limit of normal).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prehabilitation<br>exercise, nutrition and anxiety reduction in the preoperative period | Other: Prehabilitation<br>* exercise, nutrition and anxiety reduction in the preoperative period<br>|
| No Intervention: No Prehabilitation<br>Not: exercise, nutrition and anxiety reduction in the preoperative period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of prehabilitation on the change from lean mass index | Effect of prehabilitation on the lean mass index | preoperative and 1-month postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, COLON CANCER, NUTRITION