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Completed

NCT Number: NCT05714878

Multimodal Prehabilitation for Resectable Gastric Cancer

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.

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Key information

Conditions

Stomach Neoplasm Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital First Medical Center

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

aerobic exercise; resistance exercise; nutritional support; psychological support

Behavioral

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.

Primary outcomes

  1. Duke Activity Status Index before surgery

    Time frame: 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 outcomes

  1. Morbidity

    Time frame: In postoperative 30 day after gastrectomy

    Postoperative complication

  2. Postoperative hospital stay

    Time frame: During the postoperative 30 day period

    Period from day of surgery to day of discharge from hospital

  3. 30-day readmission rate

    Time frame: During the postoperative 30 day period

    Proportion of patients admitted to the hospital after discharge because of complications

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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