CancerNCT03909464
Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy
An observational study of Cancer and Malignancy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malignancy, Malignant Neoplasm
- What is being tested?
- Neurosensory testing with Pressure-Specified Sensory Device
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 25 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohorts will be selected from patients receiving inpatient or outpatient chemotherapy at Johns Hopkins Hospital.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: 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.
Read more
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
- Being tested
- Neurosensory testing with Pressure-Specified Sensory Device
- Keywords
- chemotherapy, neurosensory, neurosensory testing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurosensory testing with Pressure-Specified Sensory DeviceDevice
Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Neurosensory testing with 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 Receives: Device: Neurosensory testing with Pressure-Specified Sensory Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure-Specified Sensory Device (PSSD) Score
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.
Measured: up to 2 months post-intervention
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire module CIPN20 (EORTC QLQ-CIPN20)
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.
Measured: up to 2 months post-intervention
Secondary outcomes (1)
Michigan Neuropathy Screening Instrument (MNSI) patient reported outcomes portion.
The patient reported outcomes portion of the MNSI will be used as a secondary measure, where a higher score indicates more neuropathic symptoms.
Measured: up to 2 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start29 Nov 2017
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Axogen Corporation, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Nina Wagner-Johnston, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909464
- Sponsor's protocol ID
- J1606
- Other IDs
- IRB00090611
- Status last verified
- Nov 2019
- First submitted
- 8 Apr 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration Of The Sensitivity And Specificity Of The Pressure-Specified Sensory Device™ (PSSD) For Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03909464
- Acronym / sponsor ID
- J1606
- Conditions
- Cancer, Malignancy, Malignant Neoplasm, Neuropathy, Neuropathies Sensory, Chemotherapy-induced Peripheral Neuropathy
- Keywords
- chemotherapy, neurosensory, neurosensory testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Axogen Corporation, Johns Hopkins University
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving neurotoxic chemotherapy regimen | – | Device: Neurosensory testing with Pressure-Specified Sensory DevicePatients 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 |
| Patients receiving non-neurotoxic chemotherapy regimen | – | Device: Neurosensory testing with Pressure-Specified Sensory DevicePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohorts will be selected from patients receiving inpatient or outpatient chemotherapy at Johns Hopkins Hospital.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurosensory testing with Pressure-Specified Sensory DevicePatients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device. | Device | Patients receiving neurotoxic chemotherapy regimen, Patients receiving non-neurotoxic chemotherapy regimen |
Primary outcome
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.
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.
1 secondary outcome
Michigan Neuropathy Screening Instrument (MNSI) patient reported outcomes portion.
Time frame: up to 2 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Wagner-Johnston, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Malignancy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure-Specified Sensory Device (PSSD) Score (time frame: up to 2 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.