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Electroacupuncture for Preventing Adverse Events of Cancer Immunotherapy

NCT06891521 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-03-24

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Electroacupuncture

Patients received electroacupuncture on the day before and the first day of each ICIs treatment cycle. The electroacupuncture points selected Zusanli (ST36), Quchi (LI11), and Hegu (LI4). Patients will be positioned supine, and the acupuncturist will disinfect the local skin at the acupuncture points using 75% ethanol on cotton balls. A disposable acupuncture needle (0.3mm × 40mm) will be inserted using either a single-hand or double-hand needling technique, with rapid, direct insertion. Once the needle reaches a depth of approximately 0.5 cun, the technique of lifting, thrusting, twirling, and rotating will be applied. After obtaining "de qi", the needles will be retained for 30 minutes. Needling will be performed once every 10 minutes, and the needling technique used will be a balanced reinforcing and reducing method. Electroacupuncture will be applied using a dense-wave form, with a frequency of 2 Hz and an intensity not exceeding 10 mA.

Sponsors & Collaborators

  • Qinghai Red Cross Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2027-03-01
Completion
2028-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06891521 on ClinicalTrials.gov