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Gastric CancerPREFOGNCT04223401

Prehabilitation for Gastrectomy

A study testing Prehabilitation in people with Gastric Cancer, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 2 sites in Lithuania.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
2 sitesLithuania
Study dates
6 Feb 2020to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Lithuania2 sites

  • National Cancer Institute

    Vilnius, 09239

  • Vilnius University hospital Santaros klinikos

    Vilnius

Other trials in Lithuania

About this study

Official title: 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.

Read the 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.

Conditions
Gastric Cancer
Being tested
Prehabilitation
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
Study groups in NCT04223401
Study groupRoleWhat they receive
Prehabilitation groupExperimentalPatients in the experimental group will undergo prehabilitation before the elective surgery for gastric cancer.
Receives: Other: Prehabilitation
Control groupNo interventionPatients in the control group will not undergo prehabilitation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative morbidity rate by Clavien-Dindo

    Measured: At 90 days postoperatively

Secondary outcomes (11)

  1. Physical status by Spiroergometry

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

  2. Physical status by International Physical Activity Questionnaire (IPAQ)

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

  3. Postoperative mortality rate

    Measured: At 30 and 90 days postoperatively

  4. Nutritional status by albumin level

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

  5. Quality of Life by EORTC questionnaires

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

  6. Percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (including preoperative chemotherapy, surgery and postoperative chemotherapy)

    Measured: 12 months after surgery

  7. Physical status by grip strength test

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

  8. Physical status by 6 minutes walk test

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

  9. Physical status by the sit to stand test

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

  10. Physical status by the timed up&go test

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

  11. Psychological status by Hospital Anxiety and Depression Scale (HADS).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2020
  2. Study start6 Feb 2020
  3. Primary completion1 Oct 2023
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04223401
Sponsor's protocol ID
1
Acronym
PREFOG
Status last verified
Nov 2023
First submitted
6 Jan 2020
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37750588

  • 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.

    PubMed 32629639

Questions about this trial

What is this clinical trial studying?

A study testing Prehabilitation in people with Gastric Cancer, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 2 sites in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative morbidity rate by Clavien-Dindo (time frame: At 90 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04223401, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023; AzTrials last refreshed its copy on 4 Nov 2026.

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