NCT07839702From ClinicalTrials.govRecruiting

Multimodal Prehabilitation in Gastric Cancer Patients

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

Gastric Cancer (GC)
Prehabilitation
Postoperative Inflammation

At a glance

Phase: Phase not stated
Study type: Interventional
Sponsor: National University Hospital, Singapore
Enrolment target: 25
Started: 1 July 2026
Main results due: 31 May 2027
Study sites: 1
Registry updated: 24 September 2026

Can you take part?

Ages 22 years to 99 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Adult patients (22 to 99 years).
2. Histologically confirmed gastric or esophagogastric junction cancer (Siewert type II/III).
3. Scheduled for curative surgery (laparoscopic or robotic subtotal, total, or proximal gastrectomy).
4. No distant metastasis (M0).
5. Tolerating oral intake.
6. 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.

Exclusion Criteria:

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

National University Hospital
Singapore, Singapore
Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07839702. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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