Clinical trial NCT04223401: Prehabilitation for Gastrectomy
Official title: Personalized Trimodal Prehabilitation for Gastrectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Sponsor class: OTHER
Collaborators: name: Vilnius University
name: Vilnius University Hospital Santaros Klinikos
First posted: 2020-01-10
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Postoperative morbidity rate by Clavien-Dindo
timeFrame: At 90 days postoperatively
Secondary outcomes:
measure: Physical status by Spiroergometry
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
measure: Physical status by International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
measure: Postoperative mortality rate
timeFrame: At 30 and 90 days postoperatively
measure: Nutritional status by albumin level
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
measure: Quality of Life by EORTC questionnaires
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
measure: Percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (including preoperative chemotherapy, surgery and postoperative chemotherapy)
timeFrame: 12 months after surgery
measure: Physical status by grip strength test
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
measure: Physical status by 6 minutes walk test
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
measure: Physical status by the sit to stand test
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
measure: Physical status by the timed up&go test
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
measure: Psychological status by Hospital Anxiety and Depression Scale (HADS).
timeFrame: Baseline, pre-surgery, 3, 6 and 12 months after surgery
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Vilnius
country: Lithuania
facility: Vilnius University hospital Santaros klinikos
Study officials:
affiliation: Vilnius University
name: Kestutis Strupas, MD PhD Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.