Effect of Acupuncture for Quality of Life and Symptom Control in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stomach Neoplasms
- Sponsor
- Guangzhou University of Traditional Chinese Medicine
- Enrollment
- 240
- Locations
- 11
- Primary Endpoint
- Total AUC of FACT-Gastric TOI
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
In the investigator's pilot study(NCT 03753399), a trend of improvement of quality of life, as well as release of symptoms, in gastric patients in acupuncture groups was indicated. This study will evaluate the efficacy of acupuncture on QoL in gastric cancer patients undergoing postoperative adjuvant chemotherapy with more samples. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or non-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.
Investigators
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
- •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;
- •Can understand the study well and finish the questionnaires in this study;
- •With the written informed consent.
Exclusion Criteria
- •Can not finish the baseline assessment;
- •Needle phobia;
- •Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
- •History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
- •Implanted with heart pacemaker;
- •Has accepted neoadjuvant radiotherapy before surgery;
- •Planning to accept adjuvant radiotherapy after surgery;
- •With active infection;
- •Acupuncture treatment within the previous 6 weeks;
- •10.Pregnant or lactating women.
Outcomes
Primary Outcomes
Total AUC of FACT-Gastric TOI
Time Frame: At the end of Cycle 3 ( 21 days for one cycle)
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 (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (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. TOI for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy.
Secondary Outcomes
- Total AUC of Modified Edmonton Symptom Assessment Scale(At the end of Cycle 3 ( 21 days for one cycle))
- Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric(At the end of Cycle 3 ( 21 days for one cycle))
- Average trajectory of Modified Edmonton Symptom Assessment Scale(Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle))
- Total AUC of FACT-Gastric Scoring(At the end of Cycle 3 ( 21 days for one cycle))
- Average trajectory of FACT-Gastric TOI over time(Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle))
- Average trajectory of FACT-Gastric Scoring over time(Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle))
- Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric(Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle))