Acupuncture Combined With Chemotherapy for Gastric Cancer After Surgery

Official title

Multicenter Randomized Controlled Clinical Study on Acupuncture Combined With Adjuvant Chemotherapy for the Prevention of Recurrence and Metastasis After Gastric Cancer Surgery

Overview

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.

Interventions

• Other 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.
• 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 th
• Drug Chemotherapy
  Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen

Primary outcome measures

• Disease free survival [Time frame: From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first, assessed up to 5 years.]

Secondary outcome measures (11)

• Average trajectory of FACT-Gastric TOI over time [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]
• Total AUC of FACT-Gastric TOI [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]
• Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]
• Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]
• Average trajectory of FACT-Gastric Scoring over time [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]
• Total AUC of FACT-Gastric Scoring [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]
• Average trajectory of Modified Edmonton Symptom Assessment Scale [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]
• Total AUC of Modified Edmonton Symptom Assessment Scale [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]
• Overall survival [Time frame: From the date of surgery until the date of death from any cause, assessed up to 5 years.]
• Chemotherapy completion rate [Time frame: The number of patients who have received 8 Cycle chemotherapy divided by the total number of patients in each group, assessed up to 8 months.]
• Traditional Chinese Medicine Symptom Assessment [Time frame: Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis]

Eligibility criteria

Inclusion criteria

• 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
• Postoperative pathological diagnosis of gastric cancer, with pathological staging of pII/pIII (American Joint Committee on Cancer, AJCC)
• No recurrence or metastasis confirmed by imaging examination
• Performance Status (PS) score of 0-2
• Age between 18 and 75 years
• 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
• Signed informed consent, and the patient voluntarily accepts treatment according to this protocol

Exclusion criteria

• Unable to complete baseline assessment
• Individuals with a fear of acupuncture
• Those planning to receive postoperative adjuvant radiotherapy
• History of blood system diseases, organ transplant history, or those requiring long-term oral immunosuppressants
• Individuals with implanted cardiac pacemakers
• Those who have received acupuncture treatment within the past 6 weeks
• Fever within 3 days prior to enrollment with a temperature above 38°C or clinically significant infections(Subject to enrollment once infection is managed)
• Currently receiving or having used the investigational drug or device within 4 weeks prior to the first intervention of the study
• Presence of other primary tumors
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 3 centers

• The first affiliated hospital, Sun Yat-sen University — Guangzhou
• Guangdong Provincial Hospital of Chinese Medicine — Guangzhou
• Sixth Affiliated Hospital ,Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07098949 · 2024ZD0521302 · 2024ZD0521302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗