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

Primary Purpose

Colo-rectal Cancer, Nutrition Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colo-rectal Cancer focused on measuring COLON CANCER, ERAS, NUTRITION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Prehabilitation

    No Prehabilitation

    Arm Description

    exercise, nutrition and anxiety reduction in the preoperative period

    Not: exercise, nutrition and anxiety reduction in the preoperative period

    Outcomes

    Primary Outcome Measures

    Effect of prehabilitation on the change from lean mass index
    Effect of prehabilitation on the lean mass index

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2018
    Last Updated
    August 4, 2018
    Sponsor
    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03618329
    Brief Title
    Effect of Prehabilitation on the Lean Mass Index (IMM) in ERAS PROGRAMM.
    Acronym
    PRERAS
    Official Title
    Effect of Prehabilitation on the Lean Mass Index (IMM) in Patients Operated on for Colon Cancer in ERAS Programm.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    June 30, 2019 (Anticipated)
    Study Completion Date
    December 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colo-rectal Cancer, Nutrition Disorders
    Keywords
    COLON CANCER, ERAS, NUTRITION

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prehabilitation
    Arm Type
    Active Comparator
    Arm Description
    exercise, nutrition and anxiety reduction in the preoperative period
    Arm Title
    No Prehabilitation
    Arm Type
    No Intervention
    Arm Description
    Not: exercise, nutrition and anxiety reduction in the preoperative period
    Intervention Type
    Other
    Intervention Name(s)
    Prehabilitation
    Intervention Description
    exercise, nutrition and anxiety reduction in the preoperative period
    Primary Outcome Measure Information:
    Title
    Effect of prehabilitation on the change from lean mass index
    Description
    Effect of prehabilitation on the lean mass index
    Time Frame
    preoperative and 1-month postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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).

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34169328
    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.
    Results Reference
    derived

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