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

August 4, 2018 updated by: Antonio Arroyo Sebastian, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prehabilitation
exercise, nutrition and anxiety reduction in the preoperative period
Other: Prehabilitation
exercise, nutrition and anxiety reduction in the preoperative period
No Intervention: No Prehabilitation
Not: exercise, nutrition and anxiety reduction in the preoperative period

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

August 4, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 4, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRERAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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