Acupuncture Combined With Chemotherapy for Gastric Cancer After Surgery

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Disease free survival [Срок оценки: 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.]

Вторичные конечные точки (11)

• Average trajectory of FACT-Gastric TOI over time [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the date of surgery until the date of death from any cause, assessed up to 5 years.]
• Chemotherapy completion rate [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

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

Идентификаторы

NCT: NCT07098949 · 2024ZD0521302 · 2024ZD0521302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗