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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal prehabilitation group | Experimental | Patients received multimodal prehabilitation combined with ERAS before the gastrectomy. |
|
| ERAS group | Active Comparator | The ERAS pathway was followed in patients in the ERAS group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal prehabilitation program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanbing Zhou, MD | Contact | 86532-82911324 | zhouyanbing@qduhospital.cn | |
| Qi Liu | Contact | 86532-82911324 | lq112867@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanbing Zhou | The Affiliated Hospital of Qingdao University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital | Recruiting | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41870736 | Derived | Liu Q, Meng C, Cao S, Liu X, Tian Y, Li Z, Han L, Wang Q, Liu Z, Lv J, Liu N, Ji Q, Jiang Y, Han H, Zhao L, Niu Z, Jiang H, Sun Y, Liu G, Zhong H, Wang K, Zhou Y. The whole-course of supervised home-based multi-modal prehabilitation to improve clinical outcome in patients undergoing neoadjuvant chemotherapy prior to gastrectomy: a single-center randomized controlled trial. Gastric Cancer. 2026 May;29(3):669-679. doi: 10.1007/s10120-026-01735-w. Epub 2026 Mar 23. No abstract available. |
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| ERAS program | Behavioral | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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