Multimodal Rehabilitation on Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy

University of Chinese Academy Sciences

Status and phase

Not yet enrolling

Phase 2

Conditions

Gastric Cancer

Treatments

Drug: Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06419140

IRB-2024-349

Details and patient eligibility

About

This study has established a multidisciplinary rehabilitation team to recruit patients who underwent radical D2 gastrectomy in multiple centers and divided them into a rehabilitation group and a control group. Intervention will be carried out every time the patients come to the hospital for adjuvant chemotherapy and review. The control group uses traditional intervention model, and the rehabilitation group uses combined exercise/nutrition/psychology rehabilitation intervention.

This study is expected to promote early recovery after gastric cancer surgery through multidisciplinary rehabilitation intervention, reduce the occurrence of complications, improve patients' tolerance to adjuvant chemotherapy, and improve patients' quality of life, and hope to improve the short-term and long-term outcomes of gastric cancer patients.

Enrollment

138 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of Alzheimer's Disease
Must be able to swallow tablets
Age 18 to 75 years old
Patients with gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) confirmed by histopathology to be in pathological stage II/III (based on the eighth edition of the AJCC Cancer Staging Manual)
The patient underwent D2 radical resection within 3-6 weeks before randomization; and met the R0 resection criteria
The patient can undergo postoperative adjuvant chemotherapy after being selected into the randomization group, and the regimen is SOX/XELOX
Have not received previous anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy of the primary lesion
ECOG status score 0 or 1, with physical conditions to participate in sports training、Have sufficient bone marrow reserve function, ANC ≥1.5×109/L, platelet count ≥75×109/L, Hb ≥90 g/L before enrollment, and no bleeding tendency
Liver function test: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are all ≤ 2.5×ULN; serum bilirubin ≤ 1.5×ULN. For patients known to have Gilbert's disease: Serum bilirubin level ≤ 3ｘULN
Renal function test: Serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance > 50 ml/min (calculated according to Cockroft-Gault)
No mental illness, speech disorder or consciousness disorder, have certain understanding, communication and reading abilities, and be able to complete the questionnaire independently or with the assistance of the researcher
During the study, at least one source of social support (family member or friend) can monitor the safety and compliance of the intervention program
Can understand the situation of this study, and the patient and/or legal representative voluntarily agree to participate in this trial and sign the informed consent form.

Exclusion criteria

Receive neoadjuvant chemotherapy or radiotherapy before surgery;
Participate in other clinical trials related to health behavior within 3 months before the trial;
Treated with any other study drugs or participated in another clinical trial with therapeutic intent within 28 days before enrollment;
Uncontrolled serious medical illness that the investigator believes will affect the subject's acceptance of the rehabilitation program, such as combined serious medical illness, including severe heart disease (such as New York Heart Association (NYHA) Class II or worse congestion heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, etc.;
Lack of ability to participate in sports training (such as: disability, paralysis of lower limbs, etc.); not suitable for participating in sports training, such as those suffering from skeletal muscle diseases, fractures within 6 months; suffering from exercise contraindications (angina pectoris, within 6 months) Myocardial infarction, congestive heart failure, chronic obstructive pulmonary disease, planned hip or knee replacement, use of a walker or wheelchair, recent stroke with hemiplegia, etc.);
Those who are receiving other forms of nutritional intervention; those who refuse to use oral nutritional preparations;
There is uncontrolled mental illness;
Known active HIV, HBV and HCV infection;
Patients with malignant tumors other than gastric cancer (except current gastric cancer) within the past 5 years; are eligible if they meet all the following criteria: treatment of malignant tumors with the purpose of cure, such as fully treated cervical cancer in situ, non-melanoma skin Cancer, localized prostate cancer after radical resection (PSA ≤ 10ng/ml); at the same time, no signs of recurrence or metastasis were found based on imaging follow-up results and any disease-specific tumor markers;
Those with difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, or perforation;
Pregnant or lactating female patients, or subjects of childbearing age who refuse to take contraceptive measures;
Patients judged by the researcher to be unfit to participate in this study.