A New Diagnostic Method to Assess Paclitaxel-Induced Peri... | NCT04237194

Studies
A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy

NCT04237194

Sponsor

Carsten Dahl Mørch

Status

Unknown status

Last Update Posted

Aug 24, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Jan 15, 2020

First Submission Date that Met QC Criteria

Jan 17, 2020

First Posted Date

Jan 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2022

Last Update Posted Date

Aug 24, 2022Actual

Name	Class
Aalborg University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of many chemotherapeutic agents, especially antineoplastic agents. To limit the nerve damages, early detection and management of CIPN is crucial and leaves an urgent demand for new diagnostic tools. Perception threshold tracking has enabled assessments of nerve excitability tests of both small and large sensory nerves and may be used to assess CIPN at early stages. The purpose of this study is to examine whether a new nerve excitability test can detect changes in the membrane properties of the small and large nerve fibers during chemotherapy treatment.

In this study nerve excitability tests will be performed with 2 different electrodes using a novel perception threshold tracking technique to assess the Nerve excitability of small and large fibers. Further quantitative sensory tests (QST) will be performed to estimate the vibration threshold, warm and cool perception thresholds, heat and cold pain thresholds, and perceived intensity to static mechanic stimulations will be assessed. Symptoms of CIPN will be assessed using the Common Terminology Criteria for Adverse events scale and a Quality of Life Questionnaire CIPN twenty-item scale.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Nerve fiber excitability	The chronaxie and the rheobase to rectangular stimuli, the accommodation to triangular stimuli, and the electrotonus to subthreshold hyperpolarizing pre-pulses for large and small sensory nerves from the excitability measure.	The difference between baseline and the 6 months follow-up

Secondary Outcomes

Measure	Description	Time Frame
Change of Quantitative sensory test	The Quantitative sensory test is a reduced version of the German protokol and contains warmth and cold detection thresholds, heat and cold pain thresholds, vibration threshold and perceived intensity to mechanical stimuli.	The difference between baseline and the 6 months follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years
Histopathologically verified breast cancer
Performance Status according to WHO/ECOG (PS) 0-2
Candidate for adjuvant standard treatment with EC and Paclitaxel
Not previously treated with chemotherapeutic agents
Neurological examination without pathological findings
Willingness to voluntarily sign an informed consent

Exclusion Criteria:

Previously neoadjuvant treatment with chemotherapy
Receives prophylactic bone marrow stimulants
HIV
Diabetes mellitus
Opioid requirement
Symptomatic neurosensory disorders
Neurological diseases, such as sclerosis and epilepsy
Alcohol abuse
"Palmar-plantar erythrodysesthesia syndrome" / ulceration of hands or feet
Cannot understand written or oral information in Danish
Inability to cooperate

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Breast Cancer mainly affects women.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients receiving adjuvant chemotherapy, consisting of 3 cycles of Epirubicin and Cyclophosphamide (EC), followed by 3 cycles of Paclitaxel (9 Paclitaxel infusions).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laurids Ø Poulsen, MD, PhD	Contact	+45 97666795		laop@rn.dk
Helena Brøckner, Ba.Sc	Contact	+4529702992		hbrack15@student.aau.dk

Overall Officials

Name	Affiliation	Role
Laurids Ø Poulsen, MD, PhD	Aalborg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital	Recruiting	Aalborg	Northern Jutland	9000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

There is not a plan to make IPD available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided