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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 |
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This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or none-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 (a cycle of chemotherapy) for 9 weeks |
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| Low-dose acupuncture | Experimental | Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks |
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| 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, combining with electro-acupuncture at fixted acupoints. |
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| Measure | Description | Time Frame |
|---|---|---|
| FACT-Gastric Trial Outcome Index (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 （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（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. | At the end of Cycle 3 (each cycle is 21 days) |
| Chinese version of Edmonton symptom assessment scale (C-ESAS) | Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients. | At the end of Cycle 3 (each cycle is 21 days) |
| 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 （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（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. | Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle). |
| Average trajectory of C-ESAS over time | Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients. | Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China | ||
| Guangdong Provincial Hospital of Chinese Medicine |
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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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| Adherence to chemotherapy | Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy | At the end of 3 cycles of treatment (21 days for each cycle). |
| Concentration of Inflammatory factors in plasma detected with liquid chip | Plasma will be stored at -80℃. Inflammatory factors in plasma will be detected using a liquid chip panel when all patients have finished treatment. the panel is planned to contain 45 inflammatory factors and cytokines, including BDNF, EGF, Eotaxin, FGF-basic, GM-CSF, GROα, HGF, IFNγ, IFNα, IL-1RA, IL-1β, IL-1α, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1α, MIP-1β, NGFβ, PDGF-BB, PLGF, RANTES, SCF, SDF1α, TNFα, TNFβ, VEGF-A, VEGF-D. The panel may be changed at detection according to possible new public articles or reports. | At the end of 3 cycles of treatment (21 days for each cycle). |
| Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry | Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry | At the end of 3 cycles of treatment (21 days for each cycle). |
| Concentration of Circulating CD8+ T lymph cells detected using flow cytometry | CD8+ T lymph cells in peripheral blood will be detected using flow cytometry | At the end of 3 cycles of treatment (21 days for each cycle). |
| Number of Circulating tumor cells detected using microfluidic chip | Circulating tumor cells in peripheral blood will be detected using microfluidic chip | At the end of 3 cycles of treatment (21 days for each cycle). |
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| Affiliated Hospital of Nanjing University of Traditional Chinese Medicine | Nanjing | Jiangsu | 210000 | China |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |