Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy
NCT ID: NCT04360577
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2020-05-27
2023-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High-dose acupuncture
Acupuncture for 7 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)
acupuncture
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).
Low-dose acupuncture
Acupuncture for 3 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)
acupuncture
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).
Usual care
Chemotherapy without acupuncture
No interventions assigned to this group
Interventions
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acupuncture
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).
Eligibility Criteria
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Inclusion Criteria
* 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 organ 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
UNKNOWN
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
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
Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Haibo Zhang, Prof.
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial Hospital of Traditional Chinese Medicine
Locations
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Foshan First People's Hospital
Foshan, Guangdong, China
The first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 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, China
Fifth affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Countries
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References
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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. 2025 Oct 27:djaf309. doi: 10.1093/jnci/djaf309. Online ahead of print.
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.
Other Identifiers
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2017YFC1700603
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2018KT1226-2
Identifier Type: -
Identifier Source: org_study_id
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