Clinical trial NCT06891521: Electroacupuncture for Preventing Adverse Events of Cancer Immunotherapy
Official title: Electroacupuncture for Preventing Adverse Events Associated With Cancer Immunotherapy: A Prospective, Multicenter, Open-Label, Single-Arm Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cancer
Adverse Events
Keywords: Electroacupuncture
immunotherapy
immune-related adverse events (irAEs)
malignant tumors
Lead sponsor: Qinghai Red Cross Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the preventive effects of electroacupuncture on immune-related adverse events (irAEs) in patients with malignant solid tumors at the neoadjuvant stage, locally advanced, unresectable, or metastatic stages, who are receiving immune checkpoint inhibitors (ICIs) monotherapy, ICIs combined with anti-angiogenic agents, or ICIs combined with chemotherapy. The study will evaluate the efficacy, safety and mechanisms of electroacupuncture in preventing irAEs in a multicenter setting.

Detailed description: This study is a prospective, multicenter, open-label, single-arm clinical trial aimed at collecting data from patients with malignant solid tumors at the neoadjuvant stage, locally advanced, unresectable, or metastatic stages, who are receiving immune checkpoint inhibitors (ICIs) monotherapy, ICIs combined with anti-angiogenic agents, or ICIs combined with chemotherapy. The objective is to evaluate the efficacy and safety of electroacupuncture in preventing immune-related adverse events (irAEs). Patients who meet the inclusion and exclusion criteria will be formally enrolled after screening and providing informed consent. Eligible patients will receive electroacupuncture treatment, with the intervention occurring on the day before and the first day of each ICIs treatment cycle. During the treatment period, the incidence, severity, and timing of irAEs will be monitored through follow-up assessments. Additionally, questionnaires will be collected to evaluate the impact of electroacupuncture on quality of life. Blood samples will be collected for analysis of changes in inflammatory cytokines and peripheral blood lymphocyte subset proportions. The study will also assess primary and secondary outcomes, as well as adverse events.

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.

Primary outcomes:
measure: The overall incidence of any grade of immune-related adverse events (irAEs).
timeFrame: 48 weeks.
Secondary outcomes:
measure: The incidence of Grade ≥3 immune-related adverse events (irAEs).
timeFrame: 48 weeks.
measure: The time to onset of Grade ≥3 immune-related adverse events (irAEs).
timeFrame: 48 weeks.
measure: The time to onset of any grade of immune-related adverse events (irAEs).
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 immune-related adverse events (irAEs) associated with ICIs combination therapy.
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 treatment-related adverse events (TRAEs) associated with ICIs combined with chemotherapy.
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 immune-related adverse events (irAEs) associated with ICIs monotherapy.
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 treatment-related adverse events (TRAEs) associated with ICIs combined with anti-angiogenic agents.
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 hyperthyroidism and hypothyroidism.
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 rash.
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 hepatitis.
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 pneumonia.
timeFrame: 48 weeks.
measure: The incidence of any grade and Grade ≥3 abnormal blood glucose levels.
timeFrame: 48 weeks.
measure: Comparison of biomarker changes before and after electroacupuncture treatment.
timeFrame: 48 weeks.
measure: The incidence of adverse events related to electroacupuncture treatment.
timeFrame: 48 weeks.
measure: The evaluation of the difference in quality of life before and after electroacupuncture treatment.
timeFrame: 48 weeks.
measure: 16.Adherence to electroacupuncture treatment.
timeFrame: 48 weeks.
Other outcomes:
Locations:
city: Xining
country: China
facility: Qinghai, China, Qinghai Red Cross Hospital
state: Qinghai
Study officials:
References: