- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07839702
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Jimmy Bok Yan So, Prof.
- Numero di telefono: 69082222
- Email: sursbyj@nus.edu.sg
Luoghi di studio
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Singapore, Singapore, 119079
- Reclutamento
- National University Hospital
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Contatto:
- Jimmy Bok Yan So, Prof.
- Numero di telefono: 69082222
- Email: sursbyj@nus.edu.sg
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: multimodal prehabilitation
|
multimodal prehabilitaiton including PEMF therapy, omega-3- fatty acids enriched high-protein oral nutritional supplement, exercise, app-based support |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of participants with poor postoperative immune response
Lasso di tempo: 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
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Malattie dello stomaco
- Neoplasie allo stomaco
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Terapie
- Procedure chirurgiche, operative
- Cura del paziente
- Servizi sanitari
- Force di lavoro e servizi per le strutture sanitarie
- Esercizio
- Cura perioperatoria
- Esercizio preoperatorio
Altri numeri di identificazione dello studio
- 2025 PINGP
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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