Prehabilitation for Gastrectomy (PREFOG)

November 7, 2023 updated by: National Cancer Institute, Lithuania

Personalized Trimodal Prehabilitation for Gastrectomy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will investigate personalized trimodal prehabilitation for patients undergoing gastrectomy for gastric cancer.

Prehabilitation group:

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: The dietetic physician will perform physical examination and evaluation of the nutritional status to provide individualized care to each patient. Patients will receive personalized recommendations for the prevention or correction of malnutrition.

  2. Psychological intervention: Patients will undergo consultation by specialized onco-psychologist. The anxiety and depression level will be evaluated by HAD score and patients will be trained to perform techniques, such as relaxation to reduce and manage anxiety on at home basis.

    The psychologist also will enhance patients' motivation to comply with the exercise and nutritional aspects of the intervention.

  3. Exercise intervention: Patients will be consulted by PM&R physicians and physiotherapists and personalized exercise plans will be developed according to the results of 6MWT, AT and VO2peak. Exercises will focus on skeletal muscles and cardiopulmonary function training and the exercises feasible at home basis will be selected. All patients will undergo three supervised training sessions to learn the correct exercise techniques.

All patients will be routinely contacted to ensure compliance with prehabilitation program.

Patients scheduled for surgery first by multidisciplinary tumor board will undergo 4 weeks prehabilitation program, while patients scheduled for perioperative chemotherapy will undergo prehabilitation while neoadjuvant treatment will be administered.

Control group:

Patients will also 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 surgery or before and after neoadjuvant chemotherapy. Patients will not undergo prehabilitation.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania
        • Vilnius University hospital Santaros klinikos
      • Vilnius, Lithuania, 09239
        • National Cancer Institute

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation group
Patients in the experimental group will undergo prehabilitation before the elective surgery for gastric cancer.
Other: Prehabilitation

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
No Intervention: Control group
Patients in the control group will not undergo prehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative morbidity rate by Clavien-Dindo
Time Frame: At 90 days postoperatively
At 90 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical status by Spiroergometry
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Physical status by International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Postoperative mortality rate
Time Frame: At 30 and 90 days postoperatively
At 30 and 90 days postoperatively
Nutritional status by albumin level
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Quality of Life by EORTC questionnaires
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (including preoperative chemotherapy, surgery and postoperative chemotherapy)
Time Frame: 12 months after surgery
12 months after surgery
Physical status by grip strength test
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Physical status by 6 minutes walk test
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Physical status by the sit to stand test
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Physical status by the timed up&go test
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Psychological status by Hospital Anxiety and Depression Scale (HADS).
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Baseline, pre-surgery, 3, 6 and 12 months after surgery

Collaborators and Investigators

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

Sponsor

National Cancer Institute, Lithuania

Collaborators

Vilnius University
Vilnius University Hospital Santaros Klinikos

Investigators

  • Principal Investigator: Kestutis Strupas, MD PhD Prof., Vilnius University

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 (Actual)

February 6, 2020

Primary Completion (Actual)

October 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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