Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Procedure: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection; 2.Pathological stage II or stage III； 3.Without tumor recurrence confirmed by image examination; 4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy; 5.Age:18 75 years old； 6.ECOG score≤ 2； 7. Normal organs function, including: 7.1 Bone marrow function: absolute neutrophil count (ANC)≥1.5×10e9/L, platelet (PLT)≥100×10e9/L,hemoglobin (Hb)≥90g/L; 7.2 Kidney function: Serum creatinine (Scr)≤1.5mg/dl(133μmol/L), or creatinine clearance rate (Ccr)≥60ml/min； 7.3 Liver function: Total bilirubin (TB)≤1.5×upper limit of normal value (ULN), Alanine transaminase (ALT)≤2.5×ULN, Aspartate transaminase (AST)≤2.5×ULN； 8. Can understand the study well and finish the questionnaires in this study; 9. With the written informed consent. Exclusion Criteria: 1. Can not finish the baseline assessment; 2. Needle phobia; 3. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia); 4. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors; 5. Implanted with heart pacemaker; 6. Has accepted neoadjuvant radiotherapy before surgery; 7. Planning to accept adjuvant radiotherapy after surgery; 8. With active infection; 9. Acupuncture treatment within the previous 6 weeks; 10.Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose acupuncture<br>Acupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks | Procedure: acupuncture<br>* Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.<br>|
| Experimental: Low-dose acupuncture<br>Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks | Procedure: acupuncture<br>* Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.<br>|
| No Intervention: Usual care<br>Chemotherapy without acupuncture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Acupuncture, Quality of life, Adjuvant chemotherapy