The Impact of Multimodal Rehabilitation on the Outcomes of Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy: A Phase II, Multicenter, Open Label, and Randomized Clinical Study

Zhejiang Cancer Hospital1 site in 1 country138 target enrollmentJune 1, 2024

ConditionsGastric Cancer

InterventionsStandard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation

DrugsStandard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation

Overview

Phase: Phase 2
Intervention: Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation
Conditions: Gastric Cancer
Sponsor: Zhejiang Cancer Hospital
Enrollment: 138
Locations: 1
Primary Endpoint: Adjuvant chemotherapy completion rate
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2024

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhejiang Cancer Hospital

Responsible Party

Principal Investigator

Ying Jieer

Chief physician

Zhejiang Cancer Hospital

Eligibility Criteria

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)

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;