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NOT YET RECRUITING
NCT06891521
PHASE2

Electroacupuncture for Preventing Adverse Events of Cancer Immunotherapy

Sponsor: Qinghai Red Cross Hospital

View on ClinicalTrials.gov

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.

Official title: Electroacupuncture for Preventing Adverse Events Associated With Cancer Immunotherapy: A Prospective, Multicenter, Open-Label, Single-Arm Clinical Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2025-03-20

Completion Date

2028-06-01

Last Updated

2025-03-24

Healthy Volunteers

No

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.

Locations (1)

Qinghai, China, Qinghai Red Cross Hospital

Xining, Qinghai, China