Clinical trial NCT03618329: Effect of Prehabilitation on the Lean Mass Index (IMM) in ERAS PROGRAMM.
Official title: Effect of Prehabilitation on the Lean Mass Index (IMM) in Patients Operated on for Colon Cancer in ERAS Programm.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colo-rectal Cancer
Nutrition Disorders
Keywords: COLON CANCER
ERAS
NUTRITION
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Effect of prehabilitation on the change from lean mass index
timeFrame: preoperative and 1-month postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lopez-Rodriguez-Arias F, Sanchez-Guillen L, Aranaz-Ostariz V, Triguero-Canovas D, Lario-Perez S, Barber-Valles X, Lacueva FJ, Ramirez JM, Arroyo A. Effect of home-based prehabilitation in an enhanced recovery after surgery program for patients undergoing colorectal cancer surgery during the COVID-19 pandemic. Support Care Cancer. 2021 Dec;29(12):7785-7791. doi: 10.1007/s00520-021-06343-1. Epub 2021 Jun 24.