Skin Biopsies in Chemotherapy-Induced Neuropathy

Skin Biopsies in Chemotherapy-induced Neuropathy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00956033

Enrollment

Registered

2009-08-11

Start date

2008-11-30

Completion date

2012-02-29

Last updated

2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Peripheral Neuropathy

Keywords

Cancer, Peripheral Neuropathy, Bortezomib

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with multiple myeloma receiving bortezomib

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Netherlands

Outcome results