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| ID | Type | Description | Link |
|---|---|---|---|
| 2017YFC1700603 | Other Grant/Funding Number | The National Key Research and Development Program of China |
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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Affiliated Hospital of Nanjing University of Chinese Medicine | OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
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In the investigator's pilot study(NCT 03753399), a trend of improvement of quality of life, as well as release of symptoms, in gastric patients in acupuncture groups was indicated. This study will evaluate the efficacy of acupuncture on QoL in gastric cancer patients undergoing postoperative adjuvant chemotherapy with more samples. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or non-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose acupuncture | Experimental | Acupuncture for 7 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy) |
|
| Low-dose acupuncture | Experimental | Acupuncture for 3 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy) |
|
| Usual care | No Intervention | Chemotherapy without acupuncture |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Procedure | Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combing with electro-acupuncture at Baihui(GV20), Yintang(GV29), Neiguan(PC6), Zusanli(ST36), and Gongsun(SP4). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. TOI for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy. | At the end of Cycle 3 ( 21 days for one cycle) |
| 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 |
|---|---|---|
| Concentration of circulating myeloid-derived suppressor cells | Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry | At the end of Cycle 3 ( 21 days for one cycle) |
| Concentration of circulating Treg cells |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haibo Zhang, Prof. | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foshan First People's Hospital | Foshan | Guangdong | 528000 | China | ||
| The first affiliated hospital, Sun Yat-sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41143548 | Derived | Zhu YJ, Chang XS, Wu XY, Wang W, Diao DC, Li Y, Zhang HY, Xiao J, Zhai XH, Yu JL, Wang W, Zhou JX, Huang ZL, Zhang T, Ouyang W, Janjigian YY, Cytryn SL, Xiao ZZ, Liu YH, Zhou R, Ma HC, Chen YD, Peng JJ, Mao JJ, Zhang HB. Electro-acupuncture for quality of life during adjuvant chemotherapy in gastric cancer: a randomized trial. J Natl Cancer Inst. 2026 Apr 1;118(4):603-612. doi: 10.1093/jnci/djaf309. | |
| 37434165 |
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IPD can be obtained from the PI with application after article publication.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Southern Medical University, China | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Fifth Affiliated Hospital, Sun Yat-Sen University | OTHER |
| First People's Hospital of Foshan | OTHER |
| Yuebei People's Hospital | OTHER |
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| Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle) |
| 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. FACT-Gastric scoring for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy. | At the end of Cycle 3 ( 21 days for one cycle) |
| 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. | Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle) |
| 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. GaCS for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy. | At the end of Cycle 3 ( 21 days for one cycle) |
| 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. | Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle) |
| 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. ESAS scoring for each patient will be recorded everyday in the first week, and then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle). The AUCs are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy. | At the end of Cycle 3 ( 21 days for one cycle) |
| 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. | Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle) |
Treg cells in peripheral blood will be detected using flow cytometry
| At the end of Cycle 3 ( 21 days for one cycle) |
| Number of Circulating tumor cells | Circulating tumor cells in peripheral blood will be detected using microfluidic chip | At the end of Cycle 3 ( 21 days for one cycle) |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0. | Adverse events will be assessed during the period of 3 cycles of treatment (21 days for each cycle), since the date of randomization. Adverse events will be recorded once any side effect happens. |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| Sixth affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| The first affiliated hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Yue Bei People's Hospital | Shaoguan | Guangdong | 512025 | China |
| Fifth affiliated Hospital Sun Yat-Sen University | Zhuhai | Guangdong | 519000 | China |
| Affiliated Hospital of Nanjing University of Traditional Chinese Medicine | Nanjing | Jiangsu | 210000 | China |
| Derived |
| Chang X, Zhu Y, Zhao W, Liu Y, He Y, Chen Y, Xu D, Mao JJ, Zhang HB. Electro-acupuncture for health-related quality of life and symptoms in patients with gastric cancer undergoing adjuvant chemotherapy (EAGER): a protocol for a multicenter randomized controlled trial. Health Qual Life Outcomes. 2023 Jul 11;21(1):70. doi: 10.1186/s12955-023-02135-9. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |