Acupuncture Combined With Chemotherapy for Gastric Cancer After Surgery

Guangzhou University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Gastric Cancer

Treatments: Other: Sham Acupuncture; Other: Acupuncture; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07098949

2024ZD0521302 (Other Grant/Funding Number)

Details and patient eligibility

About

This multicenter, randomized, parallel-group clinical trial aims to evaluate the efficacy of acupuncture combined with adjuvant chemotherapy in patients with gastric cancer who have undergone surgery. Participants will be randomly assigned in a 1:1 ratio to receive either acupuncture or sham acupuncture during the adjuvant chemotherapy period.

Enrollment: 346 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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346 participants in 2 patient groups

Acupuncture Treatment Group

Experimental group

Description:

Acupuncture for three times every 3 weeks(once a week, one cycle of adjuvant chemotherapy), a total of 4 cycles of adjuvant chemotherapy.

Treatment:

Drug: Chemotherapy

Other: Acupuncture

Sham Acupuncture Group

Sham Comparator group

Description:

Sham acupuncture procedure at the same acupoints and treatment schedule as the acupuncture group, utilizing a blunt-tipped sham needle for superficial pressure.

Treatment:

Drug: Chemotherapy

Other: Sham Acupuncture