Skin Biopsies in Chemotherapy-Induced Neuropathy

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neuromuscular Diseases Paraproteinemias Peripheral Nervous System Diseases Peripheral Neuropathy Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC, Centrumlocatie en Daniel den Hoed

Rotterdam, South Holland, 3000CA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with multiple myeloma receiving bortezomib

Exclusion criteria

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

Treatment and study plan

Primary outcomes

intraepidermal nerve fiber density/pain intensity

Time frame: one timepoint, i.e. date of skin biopsy

correlation between intraepidermal nerve fiber density and pain intensity

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Aug 11, 2009
Registry last updated: Dec 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed