Gastric Cancer
Conditions
Keywords
Gastric Cancer, Accupuncture, Adjuvant chemotherapy, Recurrence
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.
Interventions
DRUGChemotherapy
Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen
OTHERAcupuncture
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.
OTHERSham 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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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 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 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. |
| 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. |
| 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 |
| 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 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. | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Traditional Chinese medicine syndrome data | Assessed on the last day of each chemotherapy cycle (each cycle is 21 days), up to treatment completion (maximum 8 cycles). | The scale evaluates symptoms (e.g., fatigue, poor appetite) scored 0-10 per item. Scores are collected by TCM physicians and reported as mean change from baseline |
| Adverse events | Assessed within 1 day prior to each cycle of chemotherapy ( 21 days per cycle), up to treatment completion (maximum 8 cycles). | Incidence of treatment-related adverse events (TRAEs) graded by CTCAE v5.0 |
Countries
China
Contacts
Primary ContactXiwu Rao, Dr
Outcome results
None listed