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

Colo-rectal Cancer Clinical Trial

— PRERAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03618329
• Other study ID #: PRERAS
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2018
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colorectal Neoplasms
• Nutrition Disorders

Intervention

Other:
• Prehabilitation
exercise, nutrition and anxiety reduction in the preoperative period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of prehabilitation on the change from lean mass index	Effect of prehabilitation on the lean mass index	preoperative and 1-month postoperative