Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT03909464

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-29
• Study Completion Date: 2019-11-25

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients receiving neurotoxic chemotherapy regimen

Patients receiving chemotherapy regimens involving known neurotoxic agents. Common neurotoxic agents include vinca alkaloids (ie. vincristine), taxanes (ie. Taxol), platins (ie. Oxaliplatin) and some other drugs beyond these categories (ie. Bortezomib).

Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device, as well as completing two questionnaires at each visit:

• EORTC-QLQ CIPN20 Questionnaire
• Michigan Neuropathy Screening Instrument Questionnaire

Neurosensory testing with Pressure-Specified Sensory Device

Intervention Type: DEVICE

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

Patients receiving non-neurotoxic chemotherapy regimen

Patients receiving chemotherapy regimens involving agents with negligible or doubtful risk of neurotoxicity.

Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device, as well as completing two questionnaires at each visit:

• EORTC-QLQ CIPN20 Questionnaire
• Michigan Neuropathy Screening Instrument Questionnaire

Neurosensory testing with Pressure-Specified Sensory Device

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age
• Any cancer diagnosis
• Scheduled to receive standard chemotherapy
• Patient's planned treatment must include a minimum of 4 cycles to a maximum of 8 cycles
• Patients scheduled to receive known neurotoxic or non-neurotoxic chemotherapies will be included
• Regimens known to be neurotoxic include: vinca alkaloids, taxanes, platinum analogs, and others at the discretion of the treating physician
• Regimens known to not be neurotoxic will be considered at the discretion of the treating physician
• For patients receiving known neurotoxic chemotherapy, concomitant therapy with non-neurotoxic chemotherapy is permitted
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Patients must possess the ability to complete questionnaires and comply with neurologic testing
• Patients must have a life expectancy of at least six months
• Patients must be able to understand and be willing to sign an IRB-approved written informed consent

Exclusion Criteria

• Treatment planned to be greater than 8 cycles or 6 months in length at start of treatment
• Anticipated failure to complete all cycles of chemotherapy at Johns Hopkins Hospital
• Obtaining chemotherapeutic treatment at another site other than Johns Hopkins Hospital
• Unwillingness to participate in planned PSSD testing
• Patients enrolled on the non-neurotoxic chemotherapy arm with known pre-existing neuropathy, or with underlying disease that predispose to neuropathy such as diabetes mellitus. Additional predisposing diseases will be at the discretion of the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axogen Corporation

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina Wagner-Johnston, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00090611

Identifier Type: OTHER

Identifier Source: secondary_id

J1606

Identifier Type: -

Identifier Source: org_study_id