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Multimodal Prehabilitation for Resectable Gastric Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05714878
Enrollment
70
Registered
2023-02-06
Start date
2023-03-22
Completion date
2023-12-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasm

Keywords

Gastric cancer

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.

Interventions

BEHAVIORALaerobic 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.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Duke Activity Status Index before surgeryDuke Activity Status Index score on the day before surgeryDuke 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

MeasureTime frameDescription
MorbidityIn postoperative 30 day after gastrectomyPostoperative complication
Postoperative hospital stayDuring the postoperative 30 day periodPeriod from day of surgery to day of discharge from hospital
30-day readmission rateDuring the postoperative 30 day periodProportion of patients admitted to the hospital after discharge because of complications

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026