Multimodal Prehabilitation for Resectable Gastric Cancer

Multimodal Prehabilitation for Patients With Resectable Gastric Cancer: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasm
• Intervention / Treatment: Behavioral: aerobic exercise; resistance exercise; nutritional support; psychological support

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital First Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duke Activity Status Index 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.	Duke Activity Status Index score on the day before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Postoperative complication	In postoperative 30 day after gastrectomy
Postoperative hospital stay	Period from day of surgery to day of discharge from hospital	During the postoperative 30 day period
30-day readmission rate	Proportion of patients admitted to the hospital after discharge because of complications	During the postoperative 30 day period

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Kecheng Zhang, Chinese PLA General Hospital First Medical Center

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Eur Heart J. 2023 Nov 7;44(42):4421.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Gastric cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: PLAGH202212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No