malignant tumour (including breast cancer, lung cancer, gastric cancer, colorectal cancer, etc.), regardless of molecular subtype or gender
Conditions
Interventions
Sponsors
People's Hospital of Jianyang City
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed by histopathology as a malignant tumour (including breast cancer, lung cancer, gastric cancer, colorectal cancer, etc.), regardless of molecular subtype or gender; 2. Aged 18-80; 3. Patients scheduled to receive a highly emetogenic chemotherapy (HEC) regimen and who are expected to complete at least one cycle of chemotherapy, including treatment-naïve patients with early- or advanced-stage disease, or patients with advanced-stage disease who have received neoadjuvant or adjuvant chemotherapy more than three months prior to first-line chemotherapy; the specific classifications of HEC regimens are as follows: (1) Anthracycline-based regimens combined with cyclophosphamide: applicable to breast cancer, lymphoma, etc., such as doxorubicin/epirubicin plus cyclophosphamide (AC/EC regimen); (2) Platinum-based regimens: Cisplatin monotherapy at a dose of >= 50 mg/m^2, or carboplatin AUC >= 4; applicable to lung cancer, gastric cancer, colorectal cancer, ovarian cancer, etc., such as cisplatin + pemetrexed, carboplatin + paclitaxel, cisplatin + fluorouracil, etc.; (3) Other highly emetogenic regimens: such as etoposide plus cisplatin, or combination chemotherapy with ifosfamide (ifosfamide dose >= 1.5 g/m^2), and other regimens clinically classified as HEC; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Able to assist with electroacupuncture treatment, biomarker testing and multi-cycle follow-up assessments; 6. Sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.On the first day of chemotherapy, the patient is scheduled to receive a chemotherapy regimen with a low risk of nausea and vomiting; 2.had received acupuncture treatment for another condition within 4 weeks prior to enrolment; 3.There are contraindications to electroacupuncture treatment (such as coagulation disorders, local skin infections, a history of pacemaker implantation, etc.); 4.Patients with severe underlying conditions affecting the heart, liver, kidneys or gastrointestinal tract who are unable to tolerate chemotherapy, electroacupuncture or olanzapine; 5.Pregnant and breastfeeding women; 6.Participants with mental illness or cognitive impairment are unable to participate in the study; 7.Participation in other clinical trials within the last month; 8.Patients who are allergic to olanzapine or any of the drugs in the four-drug antiemetic regimen; 9.Patients with severe hepatic or renal impairment (ALT/AST > 3 times the upper limit of normal, creatinine clearance < 50 ml/min) who are unable to undergo biomarker testing;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete protection rate within 120 hours of receiving chemotherapy;TNF-a; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of no significant nausea 120 hours after receiving chemotherapy;Adverse events;Treatment adherence;Functional Living Index – Vomiting Scale (FLIE) score;CINV-related subjective distress scores;Response rate within 120 hours of receiving chemotherapy;The rate of use of rescue antiemetic treatment within 120 hours of receiving chemotherapy;Quality of Life Questionnaire for Cancer Patients (QLQ-C30) score;Severity of nausea and vomiting;Rate of no nausea 120 hours after receiving chemotherapy;Acute (0–24 hours), delayed (24–120 hours) and overall (0–120 hours) rates of absence of vomiting following chemotherapy;Proportion of patients with a VAS score of 0 mm for nausea 120 hours after receiving chemotherapy;GAS;CCK;IL-6;MTL;IL-1ß; | — |
Countries
China
Contacts
Public ContactYang Jing
People's Hospital of Jianyang City
Outcome results
None listed