- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223401
Prehabilitation for Gastrectomy (PREFOG)
Personalized Trimodal Prehabilitation for Gastrectomy
Study Overview
Status
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:
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Vilnius, Lithuania
- Vilnius University Hospital Santaros Klinikos
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Vilnius, Lithuania, 09239
- National Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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:
|
No Intervention: Control group
Patients in the control group will not undergo prehabilitation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative morbidity rate by Clavien-Dindo
Time Frame: At 90 days postoperatively
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At 90 days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical status by Spiroergometry
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Physical status by International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Postoperative mortality rate
Time Frame: At 30 and 90 days postoperatively
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At 30 and 90 days postoperatively
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Nutritional status by albumin level
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Quality of Life by EORTC questionnaires
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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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
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12 months after surgery
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Physical status by grip strength test
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Physical status by 6 minutes walk test
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Physical status by the sit to stand test
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Physical status by the timed up&go test
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Psychological status by Hospital Anxiety and Depression Scale (HADS).
Time Frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Baseline, pre-surgery, 3, 6 and 12 months after surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Kestutis Strupas, MD PhD Prof., Vilnius University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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