Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer
NCT ID: NCT07183358
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-09-20
2026-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group (Standard Care Only)
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.
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.
Prehabilitation + Standard Care
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.
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 treatment adherence, and enhance quality of life.
Family members are trained to assist with supervision and compliance. The total duration is approximately 10-16 weeks, depending on the chemotherapy schedule.
Interventions
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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 treatment adherence, and enhance quality of life.
Family members are trained to assist with supervision and compliance. The total duration is approximately 10-16 weeks, depending on the chemotherapy schedule.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Zhou Yanbing
Chief Physician, Affiliated Hospital of Qingdao University
Locations
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Qingdao University Affiliated Hospital
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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QYFYEC2025-156
Identifier Type: -
Identifier Source: org_study_id
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