NCT03909464

Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy

Exploration Of The Sensitivity And Specificity Of The Pressure-Specified Sensory Device™ (PSSD) For Chemotherapy-Induced Peripheral Neuropathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-11-29
• Primary completion: 2019-11-25
• Completion: 2019-11-25
• First posted: 2019-04-10
• Last updated: 2019-11-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study