Gastric Cancer, Prehabilitation
Conditions
Keywords
Multimodal prehabilitation, Neoadjuvant chemotherapy
Brief 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.
Interventions
BEHAVIORALMultimodal prehabilitation program
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
BEHAVIORALERAS program
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.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2； 3. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma； 4. The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of radical gastrectomy was re-evaluated after neoadjuvant therapy; 5. Blood routine, liver function, kidney function, heart function and lung function were normal before neoadjuvant therapy, and there was no contraindication of chemotherapy and surgery; 6. The pregnancy test was negative within 1 month, and she was not pregnant or breastfeeding; 7. Informed consent and ability to comply with research protocols.
Exclusion criteria
1. metastasis; 2. End-stage cardiac insufficiency (LVEF\<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV; 3. Cerebral hemorrhage, cerebral infarction, TIA or central nervous system disease or mental illness within 6 months, could not cooperate with the completion of neoadjuvant therapy and pre-rehabilitation exercise; 4. Patients have severe infections (such as MODS, etc.) or have allergic reactions to chemotherapy drugs and metabolic disorders; 5. Concurrent tumors or other diseases requiring simultaneous surgery (except laparoscopic gallbladder surgery); 6. Emergency surgery is required due to tumor complications (e.g., bleeding, perforation, obstruction); 7. Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary capacity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum albumin levels | 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. |
| sarcopenia | 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. |
| completetion of neoadjuvant chemotherapy | Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks) | Discontinued due to adverse reactions |
| First exhaust and defecation | Postoperative (≤30 days after surgery) | First exhaust and defecation is used to assess the postoperative recovery course. |
| First liquid diet | Postoperative (≤30 days after surgery) | First liquid diet is used to assess the postoperative recovery course. |
| Patient's quality of life | 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. |
| Duration of postoperative hospital stay | Postoperative (≤30 days after surgery) | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. |
| Hospitalization costs | Postoperative (≤30 days after surgery) | The expense from admission to discharge |
| 3-year recurrence-free survival | 3 years | 3-year recurrence-free survival (RFS) rate |
| 3-year overall survival | 3 years | 3-year overall survival (OS) rate |
| The incidence of postoperative complications | Postoperative (≤30 days after surgery) | Refers to the incidence of early postoperative complications. |
Countries
China
Contacts
Primary ContactYanbing Zhou, MD
Backup ContactQi Liu
Outcome results
None listed