Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy
NCT Number: NCT06521541
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastric Cancer|Prehabilitation
Interventions: BEHAVIORAL: Multimodal prehabilitation program|BEHAVIORAL: ERAS program
Sponsor: The Affiliated Hospital of Qingdao University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-05-01
Locations: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong, 266000, China

Summary:
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.

Primary Outcome Measures: Cardiopulmonary capacity, The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardiopulmonary function., Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Secondary Outcome Measures: 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., 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., 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., 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, 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., Postoperative (≤30 days after surgery)|First liquid diet, First liquid diet is used to assess the postoperative recovery course., Postoperative (≤30 days after surgery)|The incidence of postoperative complications, Refers to the incidence of early postoperative complications., 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., Postoperative (≤30 days after surgery)|Hospitalization costs, The expense from admission to discharge, Postoperative (≤30 days after surgery)|3-year recurrence-free survival, 3-year recurrence-free survival (RFS) rate, 3 years|3-year overall survival, 3-year overall survival (OS) rate, 3 years