Clinical Study of Acupuncture Combined with Moxibustion in the treatment of Chemotherapy induced Peripheral Neuropathy

Phase 1

• Conditions: Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of chemotherapy, which has a serious impact on the quality of life of patients. At present, there is no targeted and reliable treatment plan. To investigate the efficacy and safety of acupuncture combined with moxibustion in the treatment of CIPN, a randomized controlled trial was conducted.; Acupuncture; Moxibustion; Chemotherapy; Peripheral neuropathy

• Registration Number: TCTR20230112003
• Lead Sponsor: Weiyu Chang and Lijiang Ji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Last Update Posted: 19 August 2024
• Study Completion: 2025-03-10

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

(1) Have received chemotherapy (complete at least one complete cycle), the primary disease condition is stable;
(2) Symptoms of chemotherapy-induced peripheral neuropathy after the end of chemotherapy;
(3) Age not less than18 years and not more than80 years;
(4) Karnofsky's performance status (KPS) score was greater than 60;
(5) Predicted survival time not less than 6 months;
(6) The patient has signed informed consent.

Exclusion Criteria

(1) A history of neuropathy, such as diabetes, multiple sclerosis, HIV and Parkinson's disease;
(2) Patients with a variety of drug allergy or allergic constitution;
(3) Patients with other neurological diseases, which may affect the evaluation of efficacy;
(4) Patients with skin damage or infection at the acupoints that were not suitable for acupuncture or moxibustion;
(5) Patients suffering from mental illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TNS , including 11 scoring items. 4 weeks evaluate the symptoms and signs of peripheral neuropathy, motor and sensory neurophysiology examination, touch, vibration perception, quality of life, etc.

Secondary Outcome Measures

Name	Time	Method
evaluate the symptoms and signs of peripheral neuropathy, motor and sensory neurophysiology examination, touch, vibration perception, quality of life, etc. 4 weeks ranging from grade 0 to grade 4