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Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03139435
Recruitment Status : Active, not recruiting
First Posted : May 4, 2017
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Stage 0 Breast Cancer Stage I Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Procedure: Biopsy Other: Questionnaire Administration Diagnostic Test: Ultrasound Tomography Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults.

SECONDARY OBJECTIVES:

I. To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults.

II. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients.

III. To determine if the above changes in nerve CSA correlate with changes on a self-reported neuropathy scale (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 [QLQ-CIPN20]) in the same TIPN patients.

IV. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same TIPN patients.

TERTIARY OBJECTIVES:

I. To assess activated mast cells in skin biopsies in TIPN patients in relation to severity of symptoms and above findings.

II. To assess serum inflammatory markers in TIPN patients in relation to severity of symptoms and above findings.

OUTLINE:

Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.

After completion of study, patients are followed up for 30 days.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
Actual Study Start Date : May 11, 2017
Actual Primary Completion Date : December 9, 2018
Estimated Study Completion Date : December 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Diagnostic (ultrasound)
Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.
Procedure: Biopsy
Undergo skin biopsy
Other Name: Bx

Other: Questionnaire Administration
Ancillary studies

Diagnostic Test: Ultrasound Tomography
Undergo peripheral nerve ultrasound




Primary Outcome Measures :
  1. Tibial nerve cross-sectional area [ Time Frame: Up to 30 days ]
    Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due


Secondary Outcome Measures :
  1. Amplitude of nerve response [ Time Frame: Up to 30 days ]
    Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.

  2. Conduction velocity of nerve response [ Time Frame: Up to 30 days ]
    Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.

  3. Distal latency of nerve response [ Time Frame: Up to 30 days ]
    Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.

  4. Nerve fiber density in the skin [ Time Frame: Up to 30 days ]
    Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and intraepidermal nerve fiber density.

  5. Self-reported neuropathy score [ Time Frame: Up to 30 days ]
    Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale.

  6. Sural nerve cross-sectional area [ Time Frame: Up to 30 days ]
    Will be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable.


Other Outcome Measures:
  1. Serum levels of inflammatory molecules [ Time Frame: Up to 30 days ]
    Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.

  2. The number of activated mast cells [ Time Frame: Up to 30 days ]
    Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer (any stage)
  • Previously or currently receiving taxane-based chemotherapy
  • Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy
  • Ability and willingness to understand and sign an informed consent

Exclusion Criteria:

  • Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
  • Unable to provide history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139435


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Roy Strowd Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03139435     History of Changes
Other Study ID Numbers: IRB00043631
NCI-2017-00680 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 97217 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Taxane
Antineoplastic Agents