Multimodal Prehabilitation for Resectable Gastric Cancer
Study Details
Study Description
Brief Summary
Surgical resection is the mainstay for gastric cancer. Surgical stress response, like insulin resistance and catabolism, is inevitable and is a risk factor for postoperative outcome. To cope with this stress, the enhanced recovery protocol has been proposed and successfully implemented in clinical practice. Recently, prehabilitation have attracted increasingly attention, which is the preoperative part of enhanced recovery pathway. Prehabtilitation are bundles of evidenced elements in order to improve patient's functional capacity. Patients with gastric cancer are usually suffered from nutritional risk, anxiety and frailty. In this trial, we investigate whether multimodal prehabilitation (exercise, nutrition and psychological support) could improve patient's functional status to better tolerate surgical trauma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prehabilitation arm Patient receives prehabilitation intervention including exercise, nutrition and psychological support. |
Behavioral: aerobic exercise; resistance exercise; nutritional support; psychological support
Patient with gastric cancer received two weeks of prehabilitation intervention. An individualized exercise program was established according to the FITT (Frequency, Intensity, Time and Type) principle. Aerobic exercise: 3-5 times/week, 30-60 min jogging or brisk walking per time, intensity based on heart rate and modified Borg-scale. Resistance exercise: 2-3 times/week, 10-12 RM per sets, 2-3 sets with 2 min interval rest, seated knee up, knee extension, etc. Nutritional support: 30kcal/kg/d, 1.5mg/kg/d protein, oral nutritional supplement with suggested recipes. Psychological support: provided with guidance on gastric cancer, regular online chat through Wechat, alcohol quitting, smoking cessation and light music.
|
| No Intervention: Control arm Patient receives regular care recommended by the WHO without supervision and support. |
Outcome Measures
Primary Outcome Measures
- Duke Activity Status Index before surgery [Duke Activity Status Index score on the day before surgery]
Duke Activity Status Index score is a 12-item self-reported questionnaire that assesses daily activities such as personal care, ambulation, household tasks, and recreation with respective metabolic costs. Duke Activity Status Index score ranges from 0 to 58.2. The higher score indicates the better functional status. Duke Activity Status Index has been recommended by European Society of Cardiology guidelines for functional assessment of patients undergoing non-cardiac surgery.
Secondary Outcome Measures
- Morbidity [In postoperative 30 day after gastrectomy]
Postoperative complication
- Postoperative hospital stay [During the postoperative 30 day period]
Period from day of surgery to day of discharge from hospital
- 30-day readmission rate [During the postoperative 30 day period]
Proportion of patients admitted to the hospital after discharge because of complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically confirmed gastric cancer, clinical I-III TNM stage (AJCC 8th edition);
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Will receive curative-intent surgery;
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Life expectance > 6 months;
Exclusion Criteria:
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Gastric stump cancer or combined with other malignances;
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NYHA III, NYHA IV;
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Inability to swallow, with gastrostomy, or inability to move because of orthopedic disease or neuromuscular disease;
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Psychiatric disorders, COPD, end-stage hepatic or renal disease, uncontrolled cardiac arhythmia or uncontrolled hypertention;
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Receiving immunosuppressive therapy;
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Emergency surgery because of tumor bleeding or tumor perforation;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chinese PLA General Hospital
Investigators
- Principal Investigator: Kecheng Zhang, Chinese PLA General Hospital First Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K; ESC Scientific Document Group; Knuuti J, Kristensen SD, Aboyans V, Ahrens I, Antoniou S, Asteggiano R, Atar D, Baumbach A, Baumgartner H, Bohm M, Borger MA, Bueno H, Celutkiene J, Chieffo A, Cikes M, Darius H, Delgado V, Devereaux PJ, Duncker D, Falk V, Fauchier L, Habib G, Hasdai D, Huber K, Iung B, Jaarsma T, Konradi A, Koskinas KC, Kotecha D, Landmesser U, Lewis BS, Linhart A, Lochen ML, Maeng M, Manzo-Silberman S, Mindham R, Neubeck L, Nielsen JC, Petersen SE, Prescott E, Rakisheva A, Saraste A, Sibbing D, Siller-Matula J, Sitges M, Stankovic I, Storey RF, Ten Berg J, Thielmann M, Touyz RM. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022 Oct 14;43(39):3826-3924. doi: 10.1093/eurheartj/ehac270. No abstract available.
- Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
- PLAGH202212