- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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:
|
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:
|
Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure-Specified Sensory Device (PSSD) Score
Time Frame: up to 2 months post-intervention
|
The PSSD Sensory Score is based on 1-point static and 2-point static pressure thresholds and 2- point distances.
Cutaneous pressure thresholds and inter-prong distances are reported by the PSSD and determined to be normal or abnormal at a 99% confidence limit based on age (</= 45, or >45).
These results correlate to a grading scheme which combines 1- and 2-point static pressure threshold with 2-point distance.
An increase of greater than or equal to 1 grade from baseline as measured with the PSSD will be considered a meaningful change.
The grading scale integrates normative data for each PSSD testing site.
For the index finger pulp, big toe pulp, and first dorsal webspace of the foot, the grading scale goes from 0 to 5 inclusive.
For the little finger pulp, the grading scale goes from 0 to 4 inclusive.
|
up to 2 months post-intervention
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire module CIPN20 (EORTC QLQ-CIPN20)
Time Frame: up to 2 months post-intervention
|
The CIPN20 module of the EORTC QLQ, is a validated twenty item patient-reported outcomes questionnaire used to quantify symptoms of Chemotherapy-Induced Peripheral Neuropathy.
Those whose score is greater than or equal to 0.5 standard deviation increase from baseline will be considered positive for CIPN using the EORTC QLQ-CIPN20.
|
up to 2 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Michigan Neuropathy Screening Instrument (MNSI) patient reported outcomes portion.
Time Frame: up to 2 months post-intervention
|
The patient reported outcomes portion of the MNSI will be used as a secondary measure, where a higher score indicates more neuropathic symptoms.
|
up to 2 months post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nina Wagner-Johnston, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- J1606
- IRB00090611 (Other Identifier: JHM IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Neurosensory testing with Pressure-Specified Sensory Device
-
Fisher and Paykel HealthcareTerminatedObstructive Sleep ApneaNew Zealand
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI); Cephalon; Respironics Sleep...CompletedSleep Apnea Syndromes | Lung Diseases | HypertensionUnited States, Canada
-
University Hospital, GrenobleCompleted
-
NYU Langone HealthWithdrawn
-
GE HealthcareNot yet recruiting
-
GE HealthcareRecruiting
-
McGill University Health Centre/Research Institute...United States Department of Defense; Vanderbilt University Medical Center; Hennepin...RecruitingAcute Compartment SyndromeUnited States
-
University of ZurichCompletedObstructive Sleep ApnoeaSwitzerland
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingChronic Pain | Chronic PancreatitisUnited States