The intention of research is to establish a multimodal prehabilitation protocol in patients who undergo neoadjuvant chemotherapy prior to gastrectomy, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, fitness and long-term prognosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Patients adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.Patients were evaluated for changes during neoadjuvant therapy and postoperative recovery
The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, China
RECRUITINGCardiopulmonary capacity
The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardiopulmonary function.
Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Patient's quality of life
QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status. Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status. Each index score ranges from 1 to 4, with higher scores indicating higher risk.
Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Serum albumin levels
The level of Serum albumin is used to assess nurtritional status.
Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
sarcopenia
At the L3 level, total SM will be measured. Skeletal muscle index (SMI) will be calculated as follows: SM/height(m)2. SMI is used to assess nurtritional status.
Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
completetion of neoadjuvant chemotherapy
Discontinued due to adverse reactions
Time frame: Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks)
First exhaust and defecation
First exhaust and defecation is used to assess the postoperative recovery course.
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Time frame: Postoperative (≤30 days after surgery)
First liquid diet
First liquid diet is used to assess the postoperative recovery course.
Time frame: Postoperative (≤30 days after surgery)
The incidence of postoperative complications
Refers to the incidence of early postoperative complications.
Time frame: Postoperative (≤30 days after surgery)
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: Postoperative (≤30 days after surgery)
Hospitalization costs
The expense from admission to discharge
Time frame: Postoperative (≤30 days after surgery)
3-year recurrence-free survival
3-year recurrence-free survival (RFS) rate
Time frame: 3 years
3-year overall survival
3-year overall survival (OS) rate
Time frame: 3 years