Electroacupuncture for Preventing Adverse Events of Cancer Immunotherapy

Launched by QINGHAI RED CROSS HOSPITAL · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether electroacupuncture can help prevent side effects related to cancer immunotherapy in adults with advanced cancers. Immunotherapy is a treatment that helps the body’s immune system fight cancer, but it can sometimes cause unwanted reactions known as immune-related adverse events (irAEs). The study will involve patients who are receiving their first treatment with certain types of immunotherapy and will assess how effective and safe electroacupuncture is in reducing these side effects.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of a malignant tumor, among other criteria. They should not have received specific previous treatments or have certain health conditions that could interfere with the trial. If eligible, participants can expect to receive electroacupuncture treatment alongside their cancer therapy, and the study will monitor their health and any side effects that arise. This research aims to provide valuable insights that could improve care for cancer patients undergoing immunotherapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years, any gender, any nationality.
• • 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• • 3. A definitive diagnosis of malignant tumor confirmed by pathology, and no previous treatment with PD-1/PD-L1 inhibitors.
• • 4. Patients who are receiving their first treatment with PD-1/PD-L1 inhibitors monotherapy, PD-1/PD-L1 inhibitors combined with anti-angiogenic agents, or combined chemotherapy.
• • 5. Expected survival of more than 3 months.
• • 6. Normal bone marrow and organ function.
• • 7. Premenopausal women must use adequate contraception.
• • 8. Written informed consent obtained from the patient prior to enrollment.
• Exclusion Criteria:
• • 1. Patients who have previously received or are currently receiving immunotherapy monotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with targeted therapy.
• • 2. Patients who have undergone acupuncture, radiotherapy, or surgery within 4 weeks prior to the start of treatment.
• • 3. Patients who have received any dose of systemic corticosteroid treatment within 72 hours prior to Day 1 of Cycle 1.
• • 4. Patients with active systemic autoimmune diseases within the past 2 years (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with a history of vitiligo or asthma in childhood who have been in complete remission with no intervention in adulthood may be included; subjects requiring bronchodilator medical intervention should be excluded), diagnosed with immunodeficiency or treated with immunosuppressive therapy within the past week, human immunodeficiency virus (HIV) (+), history of non-infectious pneumonia treated with glucocorticoids, pneumonia, active tuberculosis, active hepatitis B or C virus infection, or currently undergoing any systemic treatment for active infections.
• • 5. Significant abnormal laboratory values (platelet count, absolute neutrophil count, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone(TSH), adrenocorticotropic hormone (ACTH), morning cortisol, glycated hemoglobin (HbA1c), C-peptide, autoantibodies, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, prothrombin time/international normalized ratio (PT/INR), serum bilirubin, amylase, lipase, CRP).
• • 6. Skin diseases or inflammatory skin reactions that may interfere with clinical trial outcomes.
• • 7. Patients who have developed lymphedema at the site of acupuncture stimulation after receiving any acupuncture treatment.
• • 8. Patients who fear electroacupuncture stimulation or are allergic to stainless steel needles.
• • 9. Patients with psychiatric disorders, or those taking any antipsychotic or antidepressant medications.
• • 10. Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss.
• • 11. Patients with diabetes.
• • 12. Any other diseases, metabolic disorders, physical examination results, or clinical laboratory findings that raise reasonable suspicion of a disease or condition that may affect the interpretation of the outcomes or put the participant at high risk for treatment complications.
• • 13. Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
• • 14. Severe medical or psychiatric conditions.
• • 15. Any patient deemed unsuitable for enrollment by the investigator.