An interventional study of Prehabilitation in Gastric Cancer, sponsored by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos. Active, not recruiting at 2 sites in Lithuania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos · Not applicable, Interventional, and Treatment
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.
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:
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.
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.
Exclusion Criteria:
Patients in the experimental group will undergo prehabilitation before the elective surgery for gastric cancer.
Other: Prehabilitation
Patients in the control group will not undergo 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
Postoperative morbidity rate by Clavien-Dindo
Time frame: At 90 days postoperatively
Physical status by Spiroergometry
Time frame: 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
Postoperative mortality rate
Time frame: At 30 and 90 days postoperatively
Nutritional status by albumin level
Time frame: 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
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
Physical status by grip strength test
Time frame: 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
Physical status by the sit to stand test
Time frame: 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
Psychological status by Hospital Anxiety and Depression Scale (HADS).
Time frame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Plan to share: Undecided
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos