NCT04223401

Brief Summary

Prehabilitation has been demonstrated to be an effective strategy to improve outcomes in patients undergoing some of the abdominal operations. It may increase the physical capacity of the patient, improve postoperative quality of life and even decrease the postoperative morbidity. Currently, the most effective strategy seems to be a trimodal prehabilitation which includes: 1) Nutritional support 2) Psychological support and 3) Physical training.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

2 active sites

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

January 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

3.7 years

First QC Date

January 6, 2020

Last Update Submit

November 7, 2023

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Postoperative morbidity rate by Clavien-Dindo

    At 90 days postoperatively

Secondary Outcomes (11)

  • Physical status by Spiroergometry

    Baseline, pre-surgery, 3, 6 and 12 months after surgery

  • Physical status by International Physical Activity Questionnaire (IPAQ)

    Baseline, pre-surgery, 3, 6 and 12 months after surgery

  • Postoperative mortality rate

    At 30 and 90 days postoperatively

  • Nutritional status by albumin level

    Baseline, pre-surgery, 3, 6 and 12 months after surgery

  • Quality of Life by EORTC questionnaires

    Baseline, pre-surgery, 3, 6 and 12 months after surgery

  • +6 more secondary outcomes

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

Patients in the experimental group will undergo prehabilitation before the elective surgery for gastric cancer.

Other: Prehabilitation

Control group

NO INTERVENTION

Patients in the control group will not undergo prehabilitation.

Interventions

PrehabilitationOTHER

Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up \& Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve: 1. Nutritional intervention 2. Psychological intervention 3. Exercise intervention

Prehabilitation group

Eligibility Criteria

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

You may qualify if:

  • Patient ≥ 18 years old
  • Patient agrees to participate in a clinical study
  • Patient requires surgical treatment for gastric cancer

You may not qualify if:

  • Patient requiring surgical treatment for recurrent gastric cancer
  • Patient condition not allowing to postpone surgery for at least 4 weeks
  • Patients physical or mental condition which will not allow the patient to participate in prehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Institute

Vilnius, 09239, Lithuania

Location

Vilnius University hospital Santaros klinikos

Vilnius, Lithuania

Location

Related Publications (2)

  • Bausys A, Luksta M, Anglickiene G, Maneikiene VV, Kryzauskas M, Rybakovas A, Dulskas A, Kuliavas J, Stratilatovas E, Macijauskiene L, Simbelyte T, Celutkiene J, Jamontaite IE, Cirtautas A, Lenickiene S, Petrauskiene D, Cikanaviciute E, Gaveliene E, Klimaviciute G, Rauduvyte K, Bausys R, Strupas K. Effect of home-based prehabilitation on postoperative complications after surgery for gastric cancer: randomized clinical trial. Br J Surg. 2023 Nov 9;110(12):1800-1807. doi: 10.1093/bjs/znad312.

    PMID: 37750588DERIVED

  • Bausys A, Luksta M, Kuliavas J, Anglickiene G, Maneikiene V, Gedvilaite L, Celutkiene J, Jamontaite I, Cirtautas A, Lenickiene S, Vaitkeviciute D, Gaveliene E, Klimaviciute G, Bausys R, Strupas K. Personalized trimodal prehabilitation for gastrectomy. Medicine (Baltimore). 2020 Jul 2;99(27):e20687. doi: 10.1097/MD.0000000000020687.

    PMID: 32629639DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kestutis Strupas, MD PhD Prof.

    Vilnius University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 10, 2020

Study Start

February 6, 2020

Primary Completion

October 1, 2023

Study Completion

December 31, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

LI(2)