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Skin Biopsies in Chemotherapy-Induced Neuropathy

Sponsor
Erasmus Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00956033
Collaborator
(none)
26
Enrollment
1
Location
39
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    26 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Skin Biopsies in Chemotherapy-induced Neuropathy
    Study Start Date :
    Nov 1, 2008
    Actual Primary Completion Date :
    Feb 1, 2012
    Actual Study Completion Date :
    Feb 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with multiple myeloma

    Outcome Measures

    Primary Outcome Measures

    1. intraepidermal nerve fiber density/pain intensity [one timepoint, i.e. date of skin biopsy]

      correlation between intraepidermal nerve fiber density and pain intensity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with multiple myeloma receiving bortezomib
    Exclusion Criteria:

    • Patients not able to provide informed consent

    • Patients with coagulation disturbances or immunocompromised patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erasmus MC, Centrumlocatie en Daniel den Hoed Rotterdam Zuid-Holland Netherlands 3000CA

    Sponsors and Collaborators

    • Erasmus Medical Center

    Investigators

    • Principal Investigator: Joost L Jongen, Erasmus MC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Joost LM Jongen, J.L.M. Jongen, MD, PhD, Erasmus Medical Center
    ClinicalTrials.gov Identifier:
    NCT00956033
    Other Study ID Numbers:
    • MEC2008-305
    First Posted:
    Aug 11, 2009
    Last Update Posted:
    Dec 24, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Joost LM Jongen, J.L.M. Jongen, MD, PhD, Erasmus Medical Center
    Cancer
    Peripheral Neuropathy
    Bortezomib
    Additional relevant MeSH terms:
    Multiple Myeloma
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Dec 24, 2014