Acupuncture Combined With Chemotherapy for Gastric Cancer After Surgery

NCT ID: NCT07098949

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2029-02-28

Brief Summary

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture Treatment Group

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

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

The patient takes a sitting or lateral position. The following acupoints are selected Baihui (GV20), Yintang (EX-HN3), Zhongwan (CV12), Bilateral Neiguan (PC6), Bilateral Zusanli (ST36), Bilateral Sanyinjiao (SP6), Bilateral Gongsun (SP4), Bilateral Pishu (BL20). Electroacupuncture is applied at bilateral Sanyinjiao (SP6) and bilateral Zusanli (ST36) by connecting them to an electroacupuncture device. The needles are retained for 30 minutes.

Chemotherapy

Intervention Type: DRUG

Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen

Sham Acupuncture Group

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

Group Type: SHAM_COMPARATOR

Sham Acupuncture

Intervention Type: OTHER

sham acupuncture procedure that mirrors the acupuncture treatment in terms of acupoint selection and treatment schedule. However, instead of actual needle insertion, a blunt-tipped sham needle will be used to apply superficial pressure at the designated acupoints. The design of the sham needle includes a base that allows for simulated insertion, providing patients with a mild sensation of pressure and a visual cue as the needle appears to move toward the skin. This innovative approach ensures that while participants experience a similar tactile sensation, there is no penetration of the skin, distinguishing it clearly from the actual acupuncture treatment.

Chemotherapy

Intervention Type: DRUG

Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen

Interventions

Acupuncture

The patient takes a sitting or lateral position. The following acupoints are selected Baihui (GV20), Yintang (EX-HN3), Zhongwan (CV12), Bilateral Neiguan (PC6), Bilateral Zusanli (ST36), Bilateral Sanyinjiao (SP6), Bilateral Gongsun (SP4), Bilateral Pishu (BL20). Electroacupuncture is applied at bilateral Sanyinjiao (SP6) and bilateral Zusanli (ST36) by connecting them to an electroacupuncture device. The needles are retained for 30 minutes.

Intervention Type: OTHER

Sham Acupuncture

sham acupuncture procedure that mirrors the acupuncture treatment in terms of acupoint selection and treatment schedule. However, instead of actual needle insertion, a blunt-tipped sham needle will be used to apply superficial pressure at the designated acupoints. The design of the sham needle includes a base that allows for simulated insertion, providing patients with a mild sensation of pressure and a visual cue as the needle appears to move toward the skin. This innovative approach ensures that while participants experience a similar tactile sensation, there is no penetration of the skin, distinguishing it clearly from the actual acupuncture treatment.

Intervention Type: OTHER

Chemotherapy

Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haibo Zhang, Prof

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

The first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Sixth Affiliated Hospital ,Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Xiwu Rao, Dr

Role: CONTACT

18851823395@163.com

86-20-81887233

Facility Contacts

Jianjun Peng, Dr

Role: primary

aidigua@hotmail.com

86-20-28823388

Xuesong Chang

Role: primary

xuesongch2018@163.com

86-20-81887233

Jian Xiao

Role: primary

Other Identifiers

2024ZD0521302

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024ZD0521302

Identifier Type: -

Identifier Source: org_study_id