Acupuncture for chemotherapy-induced peripheral neuropathy (CIPN)

Not Applicable

• Conditions: G62.0; Drug-induced polyneuropathy

• Registration Number: DRKS00010625
• Lead Sponsor: HanseMerkur Versicherungsgesellschaft

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-09-22
• Study Start: 2016-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Clinically diagnosed chemotherapy-induced peripheral neuropathy, pathologic results of the sural nerve in nerve conduction studies

Exclusion Criteria

Current chemotherapy treatment or restart of chemotherapy due to tumor recurrence; Other diseases hat may cause peripheral neuropathy;
History of epilepsy;
Coagulopathy or use of anticoagulants with bleeding time > 3 min, prothrombin time < 40%, platelet count < 50.000/µl or PTT > 50 sec;
Bacterial infection or other skin diseases at the lower extremities;
Bone fracture of the lower extremities during the last three months;
Alcohol, opiat, analgetic, or drug abuse;
Psychiatric illnesses other than mild depression;
Incapacity of following the study instructions ;(severe language disturbances, serious cognitive deficits, lack of time);
Pregnant or breast-feeding women;
Current participation in other clinical studies.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensory sural nerve action potential amplitude (SNAP) as measured by nerve conduction studies. Evaluation at baseline, at week 14 after treatment or wait list period, and at week 28 after wait list period or treatment

Secondary Outcome Measures

Name	Time	Method
Motor tibial nerve action potential amplitude, sural and tibial nerve conduction velocity as measured by nerve conduction studies, Total Neuropathy Score, symptom related NRS questionnaire. Evaluation time points as for the primary endpoint