Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000, China
Location status: Recruiting
NCT Number: NCT06521541
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Qingdao, Shandong, 266000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
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)
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)
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)
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: Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks)
Discontinued due to adverse reactions
Time frame: Postoperative (≤30 days after surgery)
First exhaust and defecation is used to assess the postoperative recovery course.
Time frame: Postoperative (≤30 days after surgery)
First liquid diet is used to assess the postoperative recovery course.
Time frame: Postoperative (≤30 days after surgery)
Refers to the incidence of early postoperative complications.
Time frame: Postoperative (≤30 days after surgery)
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: Postoperative (≤30 days after surgery)
The expense from admission to discharge
Time frame: 3 years
3-year recurrence-free survival (RFS) rate
Time frame: 3 years
3-year overall survival (OS) rate
Contact information is provided by the study sponsor or research team.
Qi Liu
CONTACT
Yanbing Zhou, MD
CONTACT
The Affiliated Hospital of Qingdao University
Other
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy : A Single Center Randomized Control Trial
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