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

NCT07183358 | Not Yet Recruiting

• 1 other identifier: QYFYEC2025-156
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stomach Neoplasms; Neoadjuvant Therapy

Keywords

prehabilitation; postoperative complications; multimodal; family-supervised; gastric cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression)

  Baseline, before surgery, and postoperative day 7

• Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight)

  Baseline, before surgery, and postoperative day 7

• Karnofsky Performance Status (KPS) score

  Baseline, before surgery, and postoperative day 7

• Intraoperative blood loss and operative time

  Day of surgery

• Length of postoperative hospital stay

  Up to 30 days after surgery

Study Arms (2)

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.

Other: Standard Care

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.

Behavioral: Family-supervised Multimodal Prehabilitation

Interventions

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: 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.

Prehabilitation + Standard Care

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.

Control Group (Standard Care Only)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Qingdao University Affiliated Hospital

Qingdao, Shandong, 266003, China

Location

Related Publications (6)

• 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 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.

  PMID: 38677949 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.

  PMID: 26690252 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.

  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.

  PMID: 26487948 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.

  PMID: 30207593 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Postoperative Complications

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Yanbing Zhou

CONTACT

+86532-82911847; zhouyanbing999@aliyun.com

Yuanze Wei

CONTACT

+8619861122261; weiyuanze4385@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Affiliated Hospital of Qingdao University

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: September 20, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)