Clinical trial NCT03753399: Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study
Official title: Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Gastric cancer
Acupuncture
Quality of life
Adjuvant chemotherapy
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
First posted: 2018-11-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 high-dose acupuncture, low-dose acupuncture or none-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.


Eligibility criteria: 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.

Primary outcomes:
measure: FACT-Gastric Trial Outcome Index (TOI)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Chinese version of Edmonton symptom assessment scale (C-ESAS)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Average trajectory of FACT-Gastric TOI over time
timeFrame: Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle).
measure: Average trajectory of C-ESAS over time
timeFrame: 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 outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 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.
measure: Adherence to chemotherapy
timeFrame: At the end of 3 cycles of treatment (21 days for each cycle).
measure: Concentration of Inflammatory factors in plasma detected with liquid chip
timeFrame: At the end of 3 cycles of treatment (21 days for each cycle).
measure: Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry
timeFrame: At the end of 3 cycles of treatment (21 days for each cycle).
measure: Concentration of Circulating CD8+ T lymph cells detected using flow cytometry
timeFrame: At the end of 3 cycles of treatment (21 days for each cycle).
measure: Number of Circulating tumor cells detected using microfluidic chip
timeFrame: At the end of 3 cycles of treatment (21 days for each cycle).
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Nanjing
country: China
facility: Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
state: Jiangsu
Study officials:
References: