search
Back to results

Prehabilitation for Gastrectomy (PREFOG)

Primary Purpose

Gastric Cancer

Status
Active
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
National Cancer Institute, Lithuania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

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

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

Sites / Locations

  • National Cancer Institute
  • Vilnius University hospital Santaros klinikos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prehabilitation group

Control group

Arm Description

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

Patients in the control group will not undergo prehabilitation.

Outcomes

Primary Outcome Measures

Postoperative morbidity rate by Clavien-Dindo

Secondary Outcome Measures

Physical status by Spiroergometry
Physical status by International Physical Activity Questionnaire (IPAQ)
Postoperative mortality rate
Nutritional status by albumin level
Quality of Life by EORTC questionnaires
Percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (including preoperative chemotherapy, surgery and postoperative chemotherapy)
Physical status by grip strength test
Physical status by 6 minutes walk test
Physical status by the sit to stand test
Physical status by the timed up&go test
Psychological status by Hospital Anxiety and Depression Scale (HADS).

Full Information

First Posted
January 6, 2020
Last Updated
February 14, 2023
Sponsor
National Cancer Institute, Lithuania
Collaborators
Vilnius University, Vilnius University Hospital Santaros Klinikos
search

1. Study Identification

Unique Protocol Identification Number
NCT04223401
Brief Title
Prehabilitation for Gastrectomy
Acronym
PREFOG
Official Title
Personalized Trimodal Prehabilitation for Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Lithuania
Collaborators
Vilnius University, Vilnius University Hospital Santaros Klinikos

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
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.
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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation group
Arm Type
Experimental
Arm Description
Patients in the experimental group will undergo prehabilitation before the elective surgery for gastric cancer.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group will not undergo prehabilitation.
Intervention Type
Other
Intervention Name(s)
Prehabilitation
Intervention Description
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: Nutritional intervention Psychological intervention Exercise intervention
Primary Outcome Measure Information:
Title
Postoperative morbidity rate by Clavien-Dindo
Time Frame
At 90 days postoperatively
Secondary Outcome Measure Information:
Title
Physical status by Spiroergometry
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Title
Physical status by International Physical Activity Questionnaire (IPAQ)
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Title
Postoperative mortality rate
Time Frame
At 30 and 90 days postoperatively
Title
Nutritional status by albumin level
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Title
Quality of Life by EORTC questionnaires
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Title
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
Title
Physical status by grip strength test
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Title
Physical status by 6 minutes walk test
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Title
Physical status by the sit to stand test
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Title
Physical status by the timed up&go test
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery
Title
Psychological status by Hospital Anxiety and Depression Scale (HADS).
Time Frame
Baseline, pre-surgery, 3, 6 and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kestutis Strupas, MD PhD Prof.
Organizational Affiliation
Vilnius University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Vilnius
ZIP/Postal Code
09239
Country
Lithuania
Facility Name
Vilnius University hospital Santaros klinikos
City
Vilnius
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32629639
Citation
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.
Results Reference
derived

Learn more about this trial

Prehabilitation for Gastrectomy

We'll reach out to this number within 24 hrs