Clinical trial NCT05714878: Multimodal Prehabilitation for Resectable Gastric Cancer
Official title: Multimodal Prehabilitation for Patients With Resectable Gastric Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasm
Keywords: Gastric cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed gastric cancer, clinical I-III TNM stage (AJCC 8th edition);
* Will receive curative-intent surgery;
* Life expectance \> 6 months;

Exclusion Criteria:

* Gastric stump cancer or combined with other malignances;
* NYHA III, NYHA IV;
* Inability to swallow, with gastrostomy, or inability to move because of orthopedic disease or neuromuscular disease;
* Psychiatric disorders, COPD, end-stage hepatic or renal disease, uncontrolled cardiac arhythmia or uncontrolled hypertention;
* Receiving immunosuppressive therapy;
* Emergency surgery because of tumor bleeding or tumor perforation;

Primary outcomes:
measure: Duke Activity Status Index before surgery
timeFrame: Duke Activity Status Index score on the day before surgery
Secondary outcomes:
measure: Morbidity
timeFrame: In postoperative 30 day after gastrectomy
measure: Postoperative hospital stay
timeFrame: During the postoperative 30 day period
measure: 30-day readmission rate
timeFrame: During the postoperative 30 day period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital First Medical Center
Study officials:
affiliation: Chinese PLA General Hospital First Medical Center
name: Kecheng Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 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.
citation: 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.