Skin Biopsies in Chemotherapy-Induced Neuropathy

Completed

• Conditions: Multiple Myeloma; Peripheral Neuropathy

• Registration Number: NCT00956033
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. Determining intra-epidermal nerve fiber density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. In this study the investigators aim to establish the sensitivity of IENFD measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patients with multiple myeloma receiving bortezomib

Exclusion Criteria

• Patients not able to provide informed consent
• Patients with coagulation disturbances or immunocompromised patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intraepidermal nerve fiber density/pain intensity	one timepoint, i.e. date of skin biopsy	correlation between intraepidermal nerve fiber density and pain intensity

Trial Locations

Locations (1)

Erasmus MC, Centrumlocatie en Daniel den Hoed; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands