Multimodal Prehabilitation for Resectable Gastric Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Stomach Neoplasm

Intervention / Treatment
-----------------
* Behavioral: aerobic exercise; resistance exercise; nutritional support; psychological support


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation arm<br>Patient receives prehabilitation intervention including exercise, nutrition and psychological support. | Behavioral: aerobic exercise; resistance exercise; nutritional support; psychological support<br>* 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.<br>|
| No Intervention: Control arm<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer