Acupuncture & Chemotherapy for Gastric Cancer Recurrence Prevention
This study explores if acupuncture, along with chemotherapy, can help prevent gastric cancer recurrence, and how it may impact your disease-free survival.
Acupuncture
+ Chemotherapy
+ Sham Acupuncture
Digestive System Diseases+9
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This study investigates how effective acupuncture combined with additional chemotherapy is for patients who have had surgery for gastric cancer. It focuses on preventing the cancer from coming back or spreading to other parts of the body. The research targets patients who have already undergone gastric cancer surgery, aiming to provide better post-surgery care by exploring complementary therapies alongside standard cancer treatments. This is important because finding more effective ways to prevent recurrence and metastasis could significantly improve long-term health outcomes for gastric cancer patients. Participants in this study are randomly divided into two groups. One group receives acupuncture treatments, while the other group receives a pretend version of acupuncture, known as sham acupuncture, during their chemotherapy sessions. This approach helps to determine if the benefits are due to acupuncture itself or other factors. The study carefully monitors and compares how well each approach works in preventing cancer recurrence and spread. By evaluating the outcomes, researchers aim to determine whether adding acupuncture can enhance the effectiveness of chemotherapy in these patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.346 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Patients with gastric cancer who have undergone R0 resection of the stomach/ distal stomach with D2 lymphadenectomy and are planned to receive postoperative adjuvant chemotherapy 2. Postoperative pathological diagnosis of gastric cancer, with pathological staging of pII/pIII (American Joint Committee on Cancer, AJCC) 3. No recurrence or metastasis confirmed by imaging examination 4. Performance Status (PS) score of 0-2 5. Age between 18 and 75 years 6. Normal bone marrow, liver, and kidney function: * Normal bone marrow function: Neutrophil count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, hemoglobin ≥90g/L * Normal kidney function: Serum creatinine ≤1.5mg/dl (133μmol/L) and/or creatinine clearance ≥60ml/min * Normal liver function: Total serum bilirubin level ≤1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) ≤2.5 times ULN 7. Signed informed consent, and the patient voluntarily accepts treatment according to this protocol Exclusion Criteria: 1. Unable to complete baseline assessment 2. Individuals with a fear of acupuncture 3. Those planning to receive postoperative adjuvant radiotherapy 4. History of blood system diseases, organ transplant history, or those requiring long-term oral immunosuppressants 5. Individuals with implanted cardiac pacemakers 6. Those who have received acupuncture treatment within the past 6 weeks 7. Fever within 3 days prior to enrollment with a temperature above 38°C or clinically significant infections(Subject to enrollment once infection is managed) 8. Currently receiving or having used the investigational drug or device within 4 weeks prior to the first intervention of the study 9. Presence of other primary tumors 10. Pregnant or breastfeeding women, individuals with mental illness, intellectual or language disabilities, those lacking legal capacity, or those whose medical or ethical reasons affect the continuation of the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
The first affiliated hospital, Sun Yat-sen University
Guangzhou, ChinaOpen The first affiliated hospital, Sun Yat-sen University in Google MapsGuangdong Provincial Hospital of Chinese Medicine
Guangzhou, ChinaSixth Affiliated Hospital ,Sun Yat-sen University
Guangzhou, China