Multimodal Prehabilitation in Gastric Cancer Patients

NCT07839702 | Recruiting

• 1 other identifier: 2025 PINGP
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm phase II trial investigates whether a multimodal prehabilitation program can attenuate the postoperative inflammatory response in patients undergoing curative gastric cancer surgery. Major abdominal surgery induces a pronounced systemic inflammatory reaction that contributes to postoperative complications, delayed recovery, impaired functional status, and reduced tolerance to adjuvant therapy. Elevated postoperative C-reactive protein (CRP) trajectories have been associated with infectious complications, whereas a timely decline in CRP may reflect a more adequate immune response. Interventions that improve nutritional status, physical fitness, and psychological resilience before surgery may modulate these inflammatory processes. The PING-P intervention combines three components starting two weeks before surgery and continuing for three weeks postoperatively: (1) structured exercise including resistance, aerobic and respiratory training supported by pulsed electromagnetic field (PEMF) therapy to both thighs twice weekly; (2) individualized nutritional therapy with counseling and provision of omega-3-enriched high-protein oral nutritional supplements twice daily to achieve ≥1.2 g/kg/day protein intake; and (3) psychological support using coaching and digital relaxation tools. The program is delivered in hospital and at home using a mobile application with regular monitoring and feedback. The primary objective is to evaluate whether this multimodal approach reduces the proportion of patients with a poor postoperative immune response, defined as either a CRP peak ≥166 mg/L or a decrease from peak CRP to two days later of \<35%. CRP will be measured from postoperative day (POD) 1 to POD7 or until discharge. Secondary objectives include assessment of feasibility (recruitment, retention, and adherence to ONS intake, PEMF sessions, and exercises), postoperative infectious and overall complications, intervention-related adverse events, functional recovery, nutritional status, body composition, and quality of life. Adults with histologically proven gastric or esophagogastric junction cancer (Siewert II-III) scheduled for minimally-invasive curative gastrectomy at National University Hospital and Ng Teng Fong General Hospital, Singapore, will be enrolled. Exclusion criteria include distant metastases, emergency surgery, need for preoperative tube or parenteral feeding, inability to follow the program, or contraindications to oral nutrition. A total of 25 participants will be recruited. The study will provide first data on whether targeted multimodal prehabilitation can favorably modify perioperative inflammation and inform the design of a future randomized trial.

Conditions

Gastric Cancer (GC); Prehabilitation; Postoperative Inflammation

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with poor postoperative immune response

  Composite endpoint defined as either: 1. C-reactive Protein peak ≥ 166 mg/L OR 2. relative decrease in C-reactive Protein from peak to two days later \< 35% C-reactive protein will be measured from postoperative day 1 through postoperative day 7.

  From postoperative day 1 through postoperative day 7

Study Arms (1)

multimodal prehabilitation

EXPERIMENTAL

Device: prehabilitation

Interventions

prehabilitation DEVICE

multimodal prehabilitaiton including PEMF therapy, omega-3- fatty acids enriched high-protein oral nutritional supplement, exercise, app-based support

multimodal prehabilitation

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (22 to 99 years).
• Histologically confirmed gastric or esophagogastric junction cancer (Siewert type II/III).
• Scheduled for curative surgery (laparoscopic or robotic subtotal, total, or proximal gastrectomy).
• No distant metastasis (M0).
• Tolerating oral intake.
• Limited esophageal involvement (≤2 cm), no duodenal invasion. 6.7. Patients with musculoskeletal limitations (exercises will be adopted accordingly) 7.8. Informed consent provided and capable of complying with home-based program.
• No indication for total parenteral or tube feeding. 9.10. ECOG status compatible with intervention. 10.11. ASA class I-III.

You may not qualify if:

• Cognitive impairment, dementia, or psychiatric illness preventing consent or compliance.
• Emergency surgery or intraoperative conversion to open surgery.
• Need for preoperative enteral or parenteral feeding.
• Severe comorbidities requiring multiple organ resection (except cholecystectomy).
• Allergy or intolerance to components of the ONS product.
• Severe mMotor impairments affecting ability to perform exercises or complete outcome assessments.
• Patients under palliative care or rejecting curative treatment.
• Pregnant and lactating females
• Existing active electronic implants (e.g., pacemaker, defibrillator) or electromechanical medical device (e.g. insulin pump)
• Inflamed areas or skin eruptions on the legs

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119079, Singapore

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Jimmy Bok Yan So, Prof.

CONTACT

69082222; sursbyj@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: September 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-07

Locations

SG (1)