Acupuncture Combined With Chemotherapy for Gastric Cancer After Surgery

Not Applicable

Not yet recruiting

• Conditions: Gastric Cancer
• Interventions: Other: Acupuncture; Other: Sham Acupuncture; Drug: Chemotherapy

• Registration Number: NCT07098949
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-25
• Study Start: 2025-08-01
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Primary Completion: 2028-12
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 346

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Treatment Group	Acupuncture	Acupuncture for three times every 3 weeks(once a week, one cycle of adjuvant chemotherapy), a total of 4 cycles of adjuvant chemotherapy.
Sham Acupuncture Group	Sham Acupuncture	Sham acupuncture procedure at the same acupoints and treatment schedule as the acupuncture group, utilizing a blunt-tipped sham needle for superficial pressure.
Acupuncture Treatment Group	Chemotherapy	Acupuncture for three times every 3 weeks(once a week, one cycle of adjuvant chemotherapy), a total of 4 cycles of adjuvant chemotherapy.
Sham Acupuncture Group	Chemotherapy	Sham acupuncture procedure at the same acupoints and treatment schedule as the acupuncture group, utilizing a blunt-tipped sham needle for superficial pressure.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Average trajectory of FACT-Gastric TOI over time	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	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.
Total AUC of FACT-Gastric Scoring	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	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.
Average trajectory of Modified Edmonton Symptom Assessment Scale	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	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.
Total AUC of FACT-Gastric TOI	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	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.
Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric	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	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.
Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric	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	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.
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.	Record the course and dosage of adjuvant chemotherapy for patients and calculate the chemotherapy completion rate.
Average trajectory of FACT-Gastric Scoring over time	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	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.
Total AUC of Modified Edmonton Symptom Assessment Scale	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	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.
Overall survival	From the date of surgery until the date of death from any cause, assessed up to 5 years.
Traditional Chinese Medicine Symptom Assessment	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	The MDASI-TCM scale was evaluated before chemotherapy

Trial Locations

Locations (3)

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