Stomach Neoplasms
Conditions
Keywords
Gastric Cancer, Acupuncture, Quality of Life, Symptom Burden, Adjuvant Chemotherapy
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.
Interventions
PROCEDUREacupuncture
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).
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Sixth Affiliated Hospital, Sun Yat-sen University
Southern Medical University, China
Guangdong Provincial People's Hospital
The First Affiliated Hospital of Guangzhou Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Fifth Affiliated Hospital, Sun Yat-Sen University
First People's Hospital of Foshan
Yuebei People's Hospital
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total AUC of FACT-Gastric TOI | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life. |
| 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) | 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. |
| Total AUC of FACT-Gastric Scoring | 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. It is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, SOCIAL WELL BEING (SWB) SUBSCALE, EMOTIONAL WELL BEING (EWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS). The range of FACT-Gastric scoring is 0-184. The higher the score, the better the quality of life. FACT-Gastric scoring 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. |
| Total AUC of Modified Edmonton Symptom Assessment Scale | At the end of Cycle 3 ( 21 days for one cycle) | Edmonton symptom assessment scale (ESAS) is a questionnaire used for symptom assessment in cancer patients. It was composed of 10 items with score range of 0-10 for each item, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, shortness of breath, and other. ESAS was then modified in 2015, with additional symptoms of constipation and sleep. The higher the score, the worse the symptom is. ESAS scoring for each patient will be recorded everyday in the first week, and then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle). The AUCs are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy. |
| 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) | Edmonton symptom assessment scale (ESAS) is a questionnaire used for symptom assessment in cancer patients. It was composed of 10 items with score range of 0-10 for each item, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, shortness of breath, and other. ESAS was then modified in 2015, with additional symptoms of constipation and sleep. The higher the score, the worse the symptom is. |
| 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) | FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. It is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, SOCIAL WELL BEING (SWB) SUBSCALE, EMOTIONAL WELL BEING (EWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS). The range of FACT-Gastric scoring is 0-184. The higher the score, the better the quality of life. |
| Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric | At the end of Cycle 3 ( 21 days for one cycle) | The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life. GaCS 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Circulating tumor cells | At the end of Cycle 3 ( 21 days for one cycle) | Circulating tumor cells in peripheral blood will be detected using microfluidic chip |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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. | Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0. |
| Concentration of circulating myeloid-derived suppressor cells | At the end of Cycle 3 ( 21 days for one cycle) | Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry |
| Concentration of circulating Treg cells | At the end of Cycle 3 ( 21 days for one cycle) | Treg cells in peripheral blood will be detected using flow cytometry |
Countries
China
Outcome results
None listed