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NCT07839702Recruiting

Multimodal Prehabilitation in Gastric Cancer Patients

Impact of Multimodal Prehabilitation on INflammation in Patients Undergoing Gastric Cancer Surgery - a Pilot Study (PING-P-Trial)

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
25 (estimated)
First submitted
8 Feb 2026
Start date
1 Jul 2026
Primary completion date
31 May 2027
Lead sponsor
National University Hospital, Singapore
NCT number
NCT07839702

What you commit to

  • Study type: Interventional
  • Planned participants: 25
  • From 1 Jul 2026 to the primary completion date, 31 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Emergency surgery or intraoperative conversion to open surgery.
  • Severe comorbidities requiring multiple organ resection (except cholecystectomy).
  • Existing active electronic implants (e.g., pacemaker, defibrillator) or electromechanical medical device (e.g. insulin pump)

Other illness

  • Cognitive impairment, dementia, or psychiatric illness preventing consent or compliance.
  • Allergy or intolerance to components of the ONS product.

Other

  • Need for preoperative enteral or parenteral feeding.
  • Severe mMotor impairments affecting ability to perform exercises or complete outcome assessments.
  • Patients under palliative care or rejecting curative treatment.
  • Pregnant and lactating females
  • Inflamed areas or skin eruptions on the legs

Who the study is looking for

  • 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.
    • 8.9. No indication for total parenteral or tube feeding. 9.10. ECOG status compatible with intervention. 10.11. ASA class I-III.

Age in the registry: 22 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National University Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.