Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer

Официальное название

Effect of Family-Supervised Multimodal Prehabilitation Throughout Preoperative Neoadjuvant Chemotherapy on Clinical Outcomes in Gastric Cancer Patients: A Single-Center Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое Family-supervised Multimodal Prehabilitation
  A comprehensive prehabilitation program initiated at the start of neoadjuvant chemotherapy and continued until the day before surgery. The intervention includes: 1. Nutritional support: individualized dietary counseling and supplementation plans supervised by clinical nutritionists; 2. Exercise training: home-based aerobic and resistance exercises monitored via wearable devices and weekly video/phone follow-ups; 3. Psychological support: structured counseling sessions to reduce anxiety, improve
• Другое Standard Care
  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.

Первичные конечные точки

• Incidence of postoperative complications within 30 days after surgery [Срок оценки: Within 30 days after surgery]

Вторичные конечные точки (9)

• Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression) [Срок оценки: Baseline, before surgery, and postoperative day 7]
• Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight) [Срок оценки: Baseline, before surgery, and postoperative day 7]
• Karnofsky Performance Status (KPS) score [Срок оценки: Baseline, before surgery, and postoperative day 7]
• Intraoperative blood loss and operative time [Срок оценки: Day of surgery]
• Length of postoperative hospital stay [Срок оценки: Up to 30 days after surgery]
• Disease-free survival (DFS) at 6 months and 1 year [Срок оценки: 6 months and 1 year after surgery]
• Biological barrier: gut microbiota composition and diversity [Срок оценки: Baseline, before surgery, and postoperative day 7]
• Chemical barrier: fecal MUC2 protein level and goblet cell density [Срок оценки: Baseline, before surgery, and postoperative day 7]
• Immune barrier: fecal sIgA level and mucosal T-cell counts (CD3⁺, CD4⁺, CD8⁺) [Срок оценки: Baseline, before surgery, and postoperative day 7]

Критерии участия

Критерии включения

• Age 18-80 years
• Histologically proven gastric adenocarcinoma by gastroscopy
• Clinical stage T2-4a, N any, M0 planned for neoadjuvant chemotherapy plus radical gastrectomy
• ECOG performance status 0-1; ASA class I-III
• Able to understand the study and provide signed informed consent

Критерии исключения

• Previous or concurrent malignancies
• Emergent conditions (bleeding, perforation, obstruction) requiring immediate surgery
• Pregnant or lactating women
• Severe psychiatric disorders
• Prior major abdominal surgery (except laparoscopic cholecystectomy)
• Unstable angina, myocardial infarction, or cerebrovascular event within 6 months
• Continuous use of NSAIDs, corticosteroids, or probiotics within 1 month
• Simultaneous surgery for other diseases
• FEV1 < 50 % predicted
• Any condition that, in the investigator's opinion, contraindicates participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qingdao University Affiliated Hospital — Qingdao

Публикации

• 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. PMID 33921433
• 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. PMID 38677949
• 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. PMID 26690252
• 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.
• 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. PMID 26487948
• 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. PMID 30207593

Идентификаторы

NCT: NCT07183358 · QYFYEC2025-156

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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