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Acupuncture Combined With Chemotherapy for Gastric Cancer After Surgery 346 Randomized

Not yet recruiting
Clinical Trial NCT07098949 is an interventional study for Gastric Cancer and is currently not yet recruiting. Enrollment is planned to begin on 1 August 2025 and continue until the study accrues 346 participants. Led by Guangzhou University of Traditional Chinese Medicine, this study is expected to complete by 1 February 2029. The latest data from ClinicalTrials.gov was last updated on 1 August 2025.
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.
Official Title

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

Conditions
Gastric Cancer
Other Study IDs
  • 2024ZD0521302
  • 2024ZD0521302 (Other Grant/Funding Number) (Noncommunicable Chronic Diseases-National Science and Technology Major Project)
NCT ID Number
NCT07098949
Start Date (Actual)
2025-08
Last Update Posted
2025-08-01
Completion Date (Estimated)
2029-02
Enrollment (Estimated)
346
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Gastric Cancer
Accupuncture
Adjuvant chemotherapy
Recurrence
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAcupuncture 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.
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...Show More
Chemotherapy
Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen
Sham ComparatorSham 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.
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...Show More
Chemotherapy
Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Disease free survival
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
Outcome MeasureMeasure DescriptionTime Frame
Average trajectory of FACT-Gastric TOI over time
FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS) of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.
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
FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS) of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life. The area under curve (AUCs) are calculated by linear interpolation respectively, and then added together for the total AUC during the 4 cycles of chemotherapy.
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
The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life.
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
The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life. The area under curve (AUCs) are calculated by linear interpolation respectively, and then added together for the total AUC during the 4 cycles of chemotherapy.
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
FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. It is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, SOCIAL WELL BEING (SWB) SUBSCALE, EMOTIONAL WELL BEING (EWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS). The range of FACT-Gastric scoring is 0-184. The higher the score, the better the quality of life.
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
FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. It is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, SOCIAL WELL BEING (SWB) SUBSCALE, EMOTIONAL WELL BEING (EWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS). The range of FACT-Gastric scoring is 0-184. The higher the score, the better the quality of life. The area under curve (AUCs) for each cycle are calculated by linear interpolation respectively, and then added together for the total AUC during the 4 cycles of chemotherapy.
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
Edmonton symptom assessment scale (ESAS) is a questionnaire used for symptom assessment in cancer patients. It was composed of 10 items with score range of 0-10 for each item, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, shortness of breath, and other. ESAS was then modified in 2015, with additional symptoms of constipation and sleep. The higher the score, the worse the symptom is.
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
Edmonton symptom assessment scale (ESAS) is a questionnaire used for symptom assessment in cancer patients. It was composed of 10 items with score range of 0-10 for each item, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, shortness of breath, and other. ESAS was then modified in 2015, with additional symptoms of constipation and sleep. The higher the score, the worse the symptom is.The AUCs are calculated by linear interpolation respectively, and then added together for the total AUC during the 4 cycles of chemotherapy.
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
From the date of surgery until the date of death from any cause, assessed up to 5 years.
Chemotherapy completion rate
Record the course and dosage of adjuvant chemotherapy for patients and calculate the chemotherapy completion rate.
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
The MDASI-TCM scale was evaluated before chemotherapy
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  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

  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
Guangzhou University of Traditional Chinese Medicine logoGuangzhou University of Traditional Chinese Medicine49 active studies to explore
  • Sixth Affiliated Hospital, Sun Yat-sen University logoSixth Affiliated Hospital, Sun Yat-sen University
  • First Affiliated Hospital, Sun Yat-Sen University logoFirst Affiliated Hospital, Sun Yat-Sen University
Study Central Contact
Contact: Xiwu Rao, Dr, 86-20-81887233, [email protected]
3 Study Locations in 1 Countries

Guangdong

The first affiliated hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510000, China
Jianjun Peng, Dr, Contact, 86-20-28823388, [email protected]
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, 510120, China
Xuesong Chang, Contact, 86-20-81887233, [email protected]
Haibo Zhang, Prof, Principal Investigator
Sixth Affiliated Hospital ,Sun Yat-sen University, Guangzhou, Guangdong, China
Jian Xiao, Contact