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NCT00956033 Clinical Trial

Skin Biopsies in Chemotherapy-Induced Neuropathy

Multiple Myeloma Clinical Trial

Official title:
Skin Biopsies in Chemotherapy-induced Neuropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00956033
Other study ID # MEC2008-305
Secondary ID
Status Completed
Phase N/A
First received August 10, 2009
Last updated December 23, 2014
Start date November 2008
Est. completion date February 2012

Study information
Verified date December 2014
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Dutch Health Care Inspectorate
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Erasmus MC, Centrumlocatie en Daniel den Hoed Rotterdam Zuid-Holland

Sponsors (1)
Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary intraepidermal nerve fiber density/pain intensity correlation between intraepidermal nerve fiber density and pain intensity one timepoint, i.e. date of skin biopsy No
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