National University Hospital
Singapore, 119079
Location status: Recruiting
NCT Number: NCT07839702
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.
Interested in participating?
Request Info22 year–99 year
All sexes
Interventional
Not applicable
Singapore, 119079
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
multimodal prehabilitaiton including PEMF therapy, omega-3- fatty acids enriched high-protein oral nutritional supplement, exercise, app-based support
Time frame: From postoperative day 1 through postoperative day 7
Composite endpoint defined as either:
C-reactive protein will be measured from postoperative day 1 through postoperative day 7.
Contact information is provided by the study sponsor or research team.
National University Hospital, Singapore
Other
Impact of Multimodal Prehabilitation on INflammation in Patients Undergoing Gastric Cancer Surgery - a Pilot Study (PING-P-Trial)
Acronym: PING-P
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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