Prehabilitation for Gastrectomy (PREFOG)
Primary Purpose
Gastric Cancer
Status
Active
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
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
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
NCT ID
NCT04223401
First Posted
January 6, 2020
Last Updated
February 14, 2023
Sponsor
National Cancer Institute, Lithuania
Collaborators
Vilnius University, Vilnius University Hospital Santaros Klinikos
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
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