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| ID | Type | Description | Link |
|---|---|---|---|
| 2024ZD0521302 | Other Grant/Funding Number | Noncommunicable Chronic Diseases-National Science and Technology Major Project |
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| Name | Class |
|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Treatment Group | Experimental | Acupuncture for three times every 3 weeks(once a week, one cycle of adjuvant chemotherapy), a total of 4 cycles of adjuvant chemotherapy. |
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| Sham Acupuncture Group | Sham Comparator | Sham acupuncture procedure at the same acupoints and treatment schedule as the acupuncture group, utilizing a blunt-tipped sham needle for superficial pressure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | 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. |
| Measure | Description | 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. |
| Measure | Description | Time 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Traditional Chinese medicine syndrome data | 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 | Assessed on the last day of each chemotherapy cycle (each cycle is 21 days), up to treatment completion (maximum 8 cycles). |
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:
Signed informed consent, and the patient voluntarily accepts treatment according to this protocol
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiwu Rao, Dr | Contact | 86-20-81887233 | 18851823395@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Haibo Zhang, Prof | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham Acupuncture | Other | 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. |
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| Chemotherapy | Drug | Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen |
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| 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 |
| Adverse events |
Incidence of treatment-related adverse events (TRAEs) graded by CTCAE v5.0 |
| Assessed within 1 day prior to each cycle of chemotherapy ( 21 days per cycle), up to treatment completion (maximum 8 cycles). |
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
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| Sixth Affiliated Hospital ,Sun Yat-sen University | Guangzhou | Guangdong | China |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |