Status:
COMPLETED
Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study
Lead Sponsor:
Guangzhou University of Traditional Chinese Medicine
Collaborating Sponsors:
First Affiliated Hospital, Sun Yat-Sen University
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
- Pathological stage II or stage III；
- Without tumor recurrence confirmed by image examination;
- No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
- Age:18\~75 years old；
- 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
- 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;
- Pregnant or lactating women.
Key Trial Info
Start Date :
January 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2020
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03753399
Start Date
January 4 2019
End Date
April 27 2020
Last Update
May 20 2021
Active Locations (3)
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1
The first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
2
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120
3
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, China, 210000