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Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy

NCT03909464 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2019-11-27

No results posted yet for this study

Summary

Problem: A significant proportion of patients with cancer experience symptoms of sensory, motor or autonomic nerve damage from chemotherapy known as chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a major dose-limiting toxicity of many chemotherapeutic regimens. Little is known about the natural history of CIPN, and the early detection and quantification of CIPN is a significant challenge.

Design: The investigators propose a cohort study to evaluate the performance of the Pressure-Specified Sensory Device TM (PSSD) in assessing CIPN associated with various common chemotherapy regimens. The proposed study will examine peripheral nerve function before, during, and after chemotherapy treatment. Peripheral neuropathy will be assessed using the PSSD, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN-20, and the Michigan Neuropathy Screening Instrument (MNSI). These are all established and validated methods to screen for a variety of conditions that cause peripheral neuropathy.

Hypotheses: The investigators hypothesize that the PSSD will be a sensitive and specific tool for measuring CIPN. The onset of CIPN as detected by the PSSD will be compared with other screening modalities including the EORTC QLQ-CIPN20 and the MNSI.

Importance: The development of CIPN often goes unnoticed until symptoms are bothersome. Having an objective tool in the care team's armament to screen for CIPN could have a significant public health impact.

Conditions

  • Cancer
  • Malignancy
  • Malignant Neoplasm
  • Neuropathy
  • Neuropathies Sensory
  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DEVICE

Neurosensory testing with Pressure-Specified Sensory Device

Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device.

Sponsors & Collaborators

  • Axogen Corporation

    collaborator INDUSTRY

  • Johns Hopkins University

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Nina Wagner-Johnston, MD · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2019-11-25
Completion
2019-11-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909464 on ClinicalTrials.gov