Clinical trial NCT05445401: Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer
Official title: A Pilot Study of Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 6 minutes walking test
timeFrame: 1 month after surgery
measure: Scored Patient-Generated Subjective Global Assessment score
timeFrame: 1 month after surgery
measure: DMSM score
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Quality of life score QLQ-C30
timeFrame: 3 month after surgery
measure: Quality of life score QLQ-STO22
timeFrame: 3 month after surgery
measure: Postoperative skeletal muscle index of the third lumbar spine plane.
timeFrame: 3 month after surgery
measure: The rate of weight loss (≥10%) .
timeFrame: 3 month after surgery
measure: The incidence of sarcopenia.
timeFrame: 3 month after surgery
measure: The ratio of actual ONS to recommended ONS.
timeFrame: 3 month after surgery
measure: Albumin
timeFrame: 3 month after surgery
measure: Hemoglobin
timeFrame: 3 month after surgery
measure: Prealbumin.
timeFrame: 3 month after surgery
measure: Incidence of adverse reactions during neoadjuvant therapy.
timeFrame: 1 month after surgery
measure: Completion rate of neoadjuvant therapy for gastric cancer
timeFrame: 1 month after surgery
measure: Surgery rate after neoadjuvant therapy for gastric cancer.
timeFrame: 1 month after surgery
measure: TRG grading after neoadjuvant therapy for gastric cancer.
timeFrame: 1 month after surgery
measure: R0 resection rate
timeFrame: 1 month after surgery
measure: Postoperative complication rate of grade IIIa or above.
timeFrame: 3 month after surgery
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang
role: PRINCIPAL_INVESTIGATOR
References: