Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer

NCT ID: NCT05445401

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-06-30

Brief Summary

In this study, patients with traditional neoadjuvant gastric cancer were used as controls to explore whether the triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period before surgery could improve the functional reserve of neoadjuvant gastric cancer patients and accelerate postoperative recovery.

Detailed Description

Internationally, pre-rehabilitation strategies have been widely used in surgery. Due to the late start of the concept of enhanced rehabilitation in my country, the research on pre-rehabilitation in my country is still in its infancy, and the research on pre-rehabilitation in gastric cancer is basically in a blank state. Domestic scholars have compared the rehabilitation of gastric cancer patients in the exercise-based pre-rehabilitation group and the postoperative rapid rehabilitation group, and found that the postoperative stress response, insulin resistance, and inflammatory response in the pre-rehabilitation group were lower than those in the conventional treatment group, and their nutritional status was improved. faster. The pre-rehabilitation model of comprehensive exercise, nutritional support and psychological intervention is rarely used in gastric cancer patients, and there is a lack of high-quality clinical data and related research.

Neoadjuvant chemotherapy and neoadjuvant chemotherapy combined with immunotherapy are the current research hotspots in locally advanced gastric cancer. The current research studies focus on tumor regression and prognosis and survival. However, the preoperative treatment cycle of neoadjuvant gastric cancer patients is long. If there is a lack of long-term and continuous effective management and guidance during the neoadjuvant therapy, it is very easy to lead to nutritional and nutritional deficiencies after neoadjuvant therapy. The poor physical condition makes the patient suffer from physical and psychological pain.

Therefore, we considered whether it is possible to carry out effective, convenient and economical rehabilitation training treatment for neoadjuvant gastric cancer patients before surgery, so as to prevent the occurrence of surgical risks and other complications in the preoperative stage, improve the functional reserve of neoadjuvant gastric cancer patients and respond to surgery. stimulated and accelerated postoperative recovery.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-rehabilitation group

Triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period

Group Type: EXPERIMENTAL

Pre-rehabilitation

Intervention Type: BEHAVIORAL

Triple pre-rehabilitation interventions of exercise, nutrition and psychology

Conventional group

Conventional group

Group Type: PLACEBO_COMPARATOR

Standard medical care

Intervention Type: BEHAVIORAL

Traditional care

Interventions

Pre-rehabilitation

Triple pre-rehabilitation interventions of exercise, nutrition and psychology

Intervention Type: BEHAVIORAL

Standard medical care

Traditional care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Voluntarily participate in clinical research, fully understand and inform this research and sign the Informed Consent Form (ICF), and are willing to follow and have the ability to complete all experimental procedures;

2. The age when signing the informed consent form is 18 to 65 years old, male or female;

3. Advanced gastric adenocarcinoma patients diagnosed with clinical stage II-III by CT, MRI, gastroscope and pathology (based on the 8th edition UICC/AJCC staging);

4. The function of major organs is normal;

5. No history of gastric cancer surgery, chemotherapy or immunotherapy;

6. Not accompanied by systemic infection requiring antibiotic treatment;

7. After general examination, it is planned to undergo neoadjuvant immunotherapy and neoadjuvant chemotherapy followed by surgery;

8. No contraindications related to CT and MRI examinations;

9. ECOG score of 0-2 points;

Exclusion Criteria

1. The patient has a history of chemotherapy and immunotherapy in the past;

2. The patient cannot undergo CT or MRI scan, or has artifacts that cannot be assessed;

3. The patient refuses to participate in the study;

4. Patients who are going to undergo or have previously received organ or bone marrow transplantation;

5. The patient is pregnant, breastfeeding or unable to take appropriate contraceptive measures;

6. Patients with mental illness or related medical history, such as: the patient cannot understand the relevant requirements of this study;

7. Patients with human immunodeficiency virus (HIV) infection, active pulmonary tuberculosis or other severe, acute and chronic diseases that may increase the risk of participating in research and research drugs, and who are judged by the investigator to be unsuitable for participating in clinical research;

8. Other relevant factors are considered unsuitable for participating in the research by the researcher.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Quan Wang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quan Wang

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Central Contacts

Meng Li

Role: CONTACT

lm17@mails.jlu.edu.cn

18569951013

Other Identifiers

STARS-GC06

Identifier Type: -

Identifier Source: org_study_id