NCT03618329

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable colorectal-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

July 31, 2018

Last Update Submit

August 4, 2018

Conditions

Colo-rectal CancerNutrition Disorders

Keywords

COLON CANCERERASNUTRITION

Outcome Measures

Primary Outcomes (1)

  • Effect of prehabilitation on the change from lean mass index

    Effect of prehabilitation on the lean mass index

    preoperative and 1-month postoperative

Study Arms (2)

Prehabilitation

ACTIVE COMPARATOR

exercise, nutrition and anxiety reduction in the preoperative period

Other: Prehabilitation

No Prehabilitation

NO INTERVENTION

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

Interventions

PrehabilitationOTHER

exercise, nutrition and anxiety reduction in the preoperative period

Prehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Triguero-Canovas D, Lopez-Rodriguez-Arias F, Gomez-Martinez M, Sanchez-Guillen L, Peris-Castello F, Alcaide-Quiros MJ, Morillas-Blasco P, Arroyo A, Ramirez JM. Home-based prehabilitation improves physical conditions measured by ergospirometry and 6MWT in colorectal cancer patients: a randomized controlled pilot study. Support Care Cancer. 2023 Nov 6;31(12):673. doi: 10.1007/s00520-023-08140-4.

    PMID: 37930478DERIVED

  • 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.

    PMID: 34169328DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsNutrition Disorders

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 7, 2018

Study Start

October 1, 2018

Primary Completion

June 30, 2019

Study Completion

December 30, 2019

Last Updated

August 7, 2018

Record last verified: 2018-08