NCT06591078

Evaluation of Clinical Efficacy of Acupuncture in Improving Immune Response in Patients With Cervical Cancer

Clinical Efficacy Evaluation and Mechanism Study of Potential Advantageous Diseases of Acupuncture - Evaluation of Clinical Efficacy of Acupuncture in Improving Immune Response in Patients With Cervical Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ying Zhang · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In a prospective, multicenter, randomized, controlled study, patients with metastatic, recurrent, or persistent cervical cancer who were ineligible for surgery and/or radiotherapy were randomly assigned in a 1:1 ratio to either an experimental group or a control group." The control group was treated with apatinib combined with callizumab/callizumab combined with chemotherapy, and the experimental group was treated with electroacupuncture on the basis of the treatment. Anti-tumor efficacy, immune function efficacy, quality of life and safety were used as the outcome indicators.

Detailed description

1. Study Design Types: This was a prospective, multicenter, randomized controlled clinical study. 2. Random method: This study used central randomization method. A total of 90 patients with recurrent/metastatic cervical cancer were enrolled and divided into 8 research centers. Patients were divided into control group (group A) and experimental group (group B) according to the pathological type, PD-L1 expression level, immunotherapy combined with targeted therapy/immunotherapy combined with chemotherapy as stratification factors at each research center. The block length was 6, and the allocation ratio was 1∶1. 3. Control methods: This trial included a control group and an experimental group. The intervention measures of the experimental group included acupuncture + immunotherapy + targeted therapy/acupuncture + immunotherapy + chemotherapy. The intervention measures of the control group were immunotherapy + targeted therapy/immunotherapy + chemotherapy. 4. Sample size calculation: This study intends to conduct preliminary exploratory research and use small samples for clinical observation. The sample size of each group of exploratory research should be more than 30 according to literature. This exploratory study intends to include 90 patients to be allocated to the experimental group and the control group

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
OTHER	electropuncture	The needle was retained for 30 minutes. During the retention period, the needle was lifted and twisted for 3 times with even small amplitude every 10 minutes, and the complement method was performed for 3 times. No manipulation before the needle, cotton ball press directly out of the needle. ④ Frequency, course and time: Start at the same time as immunotherapy, and complete 1-2 times of electroacupuncture treatment per week; Electroacupuncture was performed 4 times per 28 days. The number of electroacupuncture treatment cycles and the number of immunotherapy courses should be consistent.

Timeline

• Start date: 2024-09-15
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-09-19
• Last updated: 2024-09-19