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Multimodal Prehabilitation in Gastric Cancer Patients (PING-P)
Impact of Multimodal Prehabilitation on INflammation in Patients Undergoing Gastric Cancer Surgery - a Pilot Study (PING-P-Trial)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Jimmy Bok Yan So, Prof.
- Telefoonnummer: 69082222
- E-mail: sursbyj@nus.edu.sg
Studie Locaties
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Singapore, Singapore, 119079
- Werving
- National University Hospital
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Contact:
- Jimmy Bok Yan So, Prof.
- Telefoonnummer: 69082222
- E-mail: sursbyj@nus.edu.sg
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: multimodal prehabilitation
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multimodal prehabilitaiton including PEMF therapy, omega-3- fatty acids enriched high-protein oral nutritional supplement, exercise, app-based support |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of participants with poor postoperative immune response
Tijdsspanne: 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. |
From postoperative day 1 through postoperative day 7
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Maagneoplasmata
- Motorische activiteit
- Beweging
- Musculoskeletale fysiologische fenomenen
- Musculoskeletale en neurale fysiologische fenomenen
- Therapeutica
- Chirurgische procedures, operatief
- Patiëntenzorg
- Gezondheidsdiensten
- Gezondheidszorgfaciliteiten personeel en diensten
- Oefening
- Perioperatieve zorg
- Preoperatieve oefening
Andere studie-ID-nummers
- 2025 PINGP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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