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This study evaluates whether a family-supervised exercise-nutrition-psychology program can reduce complications after stomach-cancer surgery. Eligible patients are adults who will receive chemotherapy before surgery. Participants are randomly assigned to either the multimodal prehabilitation program plus usual care or usual care alone. The main outcome is the rate of serious complications within 30 days after surgery. Potential benefits include fewer complications and faster recovery; risks are minimal and mainly related to mild exercise fatigue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (Standard Care Only) | Active Comparator | Participants in this arm will receive standard neoadjuvant chemotherapy followed by radical gastrectomy, along with standard ERAS (Enhanced Recovery After Surgery) perioperative management. No prehabilitation intervention will be provided. |
|
| Prehabilitation + Standard Care | Experimental | Participants will receive a family-supervised multimodal prehabilitation program throughout the neoadjuvant chemotherapy period until the day before surgery. The intervention includes personalized nutritional support, home-based exercise training, and psychological counseling, in addition to standard neoadjuvant chemotherapy, surgery, and ERAS management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-supervised Multimodal Prehabilitation | Behavioral | A comprehensive prehabilitation program initiated at the start of neoadjuvant chemotherapy and continued until the day before surgery. The intervention includes:
Family members are trained to assist with supervision and compliance. The total duration is approximately 10-16 weeks, depending on the chemotherapy schedule. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative complications within 30 days after surgery | Postoperative complications include surgical site infection, anastomotic leakage, bleeding, pneumonia, urinary tract infection, and other surgery-related adverse events occurring within 30 days after radical gastrectomy. | Within 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression) | Expression levels of tight junction proteins in intestinal mucosa, measured by immunohistochemistry or Western blot. | Baseline, before surgery, and postoperative day 7 |
| Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanbing Zhou | Contact | +86532-82911847 | zhouyanbing999@aliyun.com | |
| Yuanze Wei | Contact | +8619861122261 | weiyuanze4385@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao University Affiliated Hospital | Qingdao | Shandong | 266003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33921433 | Background | Golder HJ, Papalois V. Enhanced Recovery after Surgery: History, Key Advancements and Developments in Transplant Surgery. J Clin Med. 2021 Apr 12;10(8):1634. doi: 10.3390/jcm10081634. | |
| 38677949 | Background | Fleurent-Gregoire C, Burgess N, McIsaac DI, Chevalier S, Fiore JF Jr, Carli F, Levett D, Moore J, Grocott MP, Copeland R, Edbrooke L, Engel D, Testa GD, Denehy L, Gillis C. Towards a common definition of surgical prehabilitation: a scoping review of randomised trials. Br J Anaesth. 2024 Aug;133(2):305-315. doi: 10.1016/j.bja.2024.02.035. Epub 2024 Apr 26. |
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|
| Standard Care | Other | Standard neoadjuvant chemotherapy followed by radical gastrectomy with standard ERAS-based perioperative management, without any additional prehabilitation intervention. Participants receive routine nutritional, nursing and medical care according to hospital guidelines. The aim is to maintain current clinical practice as the control condition for comparison with the experimental prehabilitation program. |
|
Assessment of nutritional markers and body weight changes during treatment. |
| Baseline, before surgery, and postoperative day 7 |
| Karnofsky Performance Status (KPS) score | A standardized measure of functional ability and general health status. | Baseline, before surgery, and postoperative day 7 |
| Intraoperative blood loss and operative time | Total intraoperative blood loss (mL) and duration of surgery (minutes). | Day of surgery |
| Length of postoperative hospital stay | Number of days from surgery to hospital discharge. | Up to 30 days after surgery |
| Disease-free survival (DFS) at 6 months and 1 year | Time from surgery to recurrence or death from any cause. | 6 months and 1 year after surgery |
| Biological barrier: gut microbiota composition and diversity | Fecal samples will be analyzed using 16S rRNA gene sequencing to evaluate microbial diversity and composition as indicators of the biological barrier. | Baseline, before surgery, and postoperative day 7 |
| Chemical barrier: fecal MUC2 protein level and goblet cell density | Fecal MUC2 concentration measured by ELISA and goblet cell density in small intestinal mucosa assessed by histopathological staining. | Baseline, before surgery, and postoperative day 7 |
| Immune barrier: fecal sIgA level and mucosal T-cell counts (CD3⁺, CD4⁺, CD8⁺) | Fecal secretory IgA (sIgA) measured by ELISA; mucosal CD3⁺, CD4⁺, and CD8⁺ T-cell densities evaluated by immunohistochemistry. | Baseline, before surgery, and postoperative day 7 |
| 26690252 | Background | Biondi A, Lirosi MC, D'Ugo D, Fico V, Ricci R, Santullo F, Rizzuto A, Cananzi FC, Persiani R. Neo-adjuvant chemo(radio)therapy in gastric cancer: Current status and future perspectives. World J Gastrointest Oncol. 2015 Dec 15;7(12):389-400. doi: 10.4251/wjgo.v7.i12.389. |
| Background | Kang, Y.-K., Yook, J. H., Park, Y.-K., et al. (2019). Phase III randomized study of neoadjuvant chemotherapy (CT) with docetaxel (D), oxaliplatin (O) and S-1 (S) (DOS) followed by surgery and adjuvant S-1, vs surgery and adjuvant S-1, for resectable advanced gastric cancer (GC) (PRODIGY). Annals of Oncology, 30(10), 1637-1645. |
| 26487948 | Background | Newton AD, Datta J, Loaiza-Bonilla A, Karakousis GC, Roses RE. Neoadjuvant therapy for gastric cancer: current evidence and future directions. J Gastrointest Oncol. 2015 Oct;6(5):534-43. doi: 10.3978/j.issn.2078-6891.2015.047. |
| 30207593 | Background | Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D011183 | Postoperative Complications |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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