Breast CancerNCT03872141
Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients
An observational study of Breast Cancer and Chemotherapy Induced Peripheral Neuropathy, run by Yale University at 1 site in United States.
Trial summary
The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy Induced Peripheral Neuropathy, Paclitaxel Induced Neuropathy
- What is being tested?
- Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 25 Feb 2021
- 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 to 70 years
- Women only
- Adult, Older adult
Study population: Patients with Stage I-III breast cancer who will receive paclitaxel (80 mg/m2) or docetaxel (60-100mg/m2) as part of their standard of care adjuvant or neoadjuvant therapy are eligible for this study. Women of all races and ethnic groups will be eligible for this trial.
Who may be able to join
- Women ages 18 to 70 with histologically confirmed clinically stage I-III breast cancer who will receive weekly paclitaxel (80 mg/m2) or docetaxel (60-100mg/m2) chemotherapy as part of their routine care.
Who cannot join
- diabetes mellitus
- prior history of neuropathy or symptoms of numbness or peripheral pain, or prior neurotoxic chemotherapy.
- current symptoms of numbness and neuropathic pain
- treatment for bipolar disease
- treatment or concomitant use of common medications used to treat neuropathic pain, such as amitriptyline, gabapentin, pregabalin, duloxetine, for any indication
- limited English that would preclude understanding and completion of the study questionnaires
Show all 9Show fewer
- pregnancy
- life expectancy <12 weeks
- participation in other research studies either concurrent with or within 30 days prior to participation in this study may be an exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).
Read the detailed description
The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel or docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).
- Being tested
- Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer
- Keywords
- neuropathy, taxane, docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancerDiagnostic test
Quantitative measures that include additional aspects of peripheral neuropathy, such as pain, thermal allodynia, numbness and tingling are needed. We propose to evaluate several pharmacodynamics biomarkers in patients before and during chemotherapy: changes in nerve conduction velocity and amplitude, quantitative sensory testing (QST), computer based cognitive assessment, and rate of drop-out from treatment. The tests from this list that best correlate with decreased CIPN would be added to EORTC QLQ-CIPN20 scores and will provide an early indication of CIPN and/or CICI.
| Study group | Role | What they receive |
|---|---|---|
| patients with stage I-III breast cancer | Patients with Stage I-III breast cancer who will receive paclitaxel or docetaxel treatments as part of their standard of care adjuvant or neoadjuvant therapy are eligible for this study. Receives: Diagnostic Test: Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Memory Test
The phrase "Shopping List Learning" is displayed on screen. The pre-task on-screen instructions tell the test supervisor to start this task with the screen facing the supervisor so that the subject cannot see the screen. There are 3 initial rounds of this test. In the first round, the subject is told by the test supervisor: "In this task, I am going to read you a shopping list. I would like you to remember as many items from this list as possible.Total number of correct responses made in remembering the 16 word list on three consecutive learning trials. (Higher score = better performance)
Measured: 20 minutes
Information processing psychomotor function
The pre-task on-screen instructions ask: "Has the card turned over?" The test supervisor reads the full instructions to the subject from the test supervisor script. To begin the task, a playing card is presented in the center of the screen. The card will flip over so it is face up. As soon as it does, the subject must press the "Yes" key. The card will go to the back of the pack and the subject must press the "Yes" key as soon as the next card flips over and so on. The subject will practice until they reach the required number of responses, or until the practice period expires. Then, on screen instructions for the real test are presented. The test supervisor or subject must press the "Enter" key to begin the real test.
Speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score = better performance
Measured: 20 minutes
Identification
To begin the task, the test supervisor or subject must press the "Enter" key. A playing card is presented in the center of the screen. The card will flip over so it is face up. As soon as it does this the subject must decide whether the card is red or not. If it is red they should press "Yes", if it is not red they should press "No". The subject will practice until they reach the required number of responses, or until the practice period expires. Then, on screen instructions for the real test are presented. The subject should be encouraged to work as quickly as they can and be as accurate as they can.
Low score = better performance.
Measured: 20 minutes
Visual Working Memory
The pre-task on-screen instructions ask: "Is the previous card the same?" The test supervisor will read full instructions to the subject from the test supervisor script. To begin the task,a playing card is presented in the center of the screen. As soon as it does the subject must decide whether or not the card is the same as the previous one. As this is the first card in this task, the first answer is always "No". Each time a card is revealed, the subject must decide whether the card presented is the same as the one immediately presented previously, and respond by pressing the "Yes" or "No" key. The subject should be encouraged to work as quickly as they can and be as accurate as they can.
Speed of performance; mean of the log10 transformed reaction times for correct responses.
Lower score = better performance
Measured: 20 minutes
Visual Learning Memory
The pre-task on-screen instructions ask: "Have you seen this card before in this task?" The test supervisor will read full instructions to the subject from the test supervisor script.
To begin the task, the test supervisor or subject must press the "Enter" key. A playing card is presented in the center of the screen. As soon as it does the subject must decide whether or not the same card has been seen before in this task. Therefore, the first answer is always "No". Each time a card is revealed, the subject must decide whether they have been shown that card before in this task and respond by pressing the "Yes" or "No" key. The subject should be encouraged to work as quickly as they can and be as accurate as they can.
Accuracy of performance; arcsine transformation of the proportion of correct responses.
Higher score = better performance
Measured: 20 minutes
Verbal Memory Test - Delay
The test supervisor presses the "ENTER" key to begin and instructs the subject "Tell me as many of the items on the shopping list that you learned earlier as you can remember now." They then note all of the items recalled by the subject by clicking/touching the corresponding button on screen with the stylus or mouse.
Total number of correct responses made in recalling the 16 words learned previously after a delay. (Higher score = better performance
Measured: 20 minutes
Secondary outcomes (3)
To correlate neuronal calcium sensor 1 (NCS1) levels with development of chemotherapy-induced peripheral neuropathy (CIPN) and/or chemotherapy-induced cognitive impairment (CICI) in human patients.
Blood samples will be collected in heparinized tubes before the first paclitaxel/docetaxel treatment (baseline). We will collect approximately 20 mL of blood from each subject. White blood cells will be isolated using standard procedures. NCS1 levels will be assessed by Western blot analysis and by qPCR. Additional parameters will be monitored, especially if the variability in NCS1 levels is large. Parameters will be chosen from our understanding of the biochemical pathways identified in the Ehrlich laboratory as part of a separate on-going basic project. The prospective NCS1 values will be correlated with the assessment of CIPN and CICI in each patient obtained in Aim 1.
Measured: baseline
To correlate NCS1 levels with development of CIPN and/or CICI in human patients.
Blood samples will be collected in heparinized tubes before the first paclitaxel/docetaxel treatment and at week 6 during therapy. We will collect approximately 20 mL of blood from each subject. White blood cells will be isolated using standard procedures. NCS1 levels will be assessed by Western blot analysis and by qPCR. Additional parameters will be monitored, especially if the variability in NCS1 levels is large. Parameters will be chosen from our understanding of the biochemical pathways identified in the Ehrlich laboratory as part of a separate on-going basic project. The prospective NCS1 values will be correlated with the assessment of CIPN and CICI in each patient obtained in Aim 1.
Measured: 6 weeks
To correlate NCS1 levels with development of CIPN and/or CICI in human patients.
Blood samples will be collected in heparinized tubes before the first paclitaxel/docetaxel treatment at week 12 during therapy. We will collect approximately 20 mL of blood from each subject. White blood cells will be isolated using standard procedures. NCS1 levels will be assessed by Western blot analysis and by qPCR. Additional parameters will be monitored, especially if the variability in NCS1 levels is large. Parameters will be chosen from our understanding of the biochemical pathways identified in the Ehrlich laboratory as part of a separate on-going basic project. The prospective NCS1 values will be correlated with the assessment of CIPN and CICI in each patient obtained in Aim 1.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start23 May 2017
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Ehrlich, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872141
- Sponsor's protocol ID
- 2000020709
- Status last verified
- Apr 2021
- First submitted
- 7 Mar 2019
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03872141
- Acronym / sponsor ID
- 2000020709
- Keywords
- neuropathy, taxane, docetaxel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 13 Mar 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.
The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).
Detailed description
The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel or docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with stage I-III breast cancer | – | Diagnostic Test: Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancerPatients with Stage I-III breast cancer who will receive paclitaxel or docetaxel treatments as part of their standard of care adjuvant or neoadjuvant therapy are eligible for this study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with Stage I-III breast cancer who will receive paclitaxel (80 mg/m2) or docetaxel (60-100mg/m2) as part of their standard of care adjuvant or neoadjuvant therapy are eligible for this study. Women of all races and ethnic groups will be eligible for this trial.
Key inclusion criteria (1 listed)
- Women ages 18 to 70 with histologically confirmed clinically stage I-III breast cancer who will receive weekly paclitaxel (80 mg/m2) or docetaxel (60-100mg/m2) chemotherapy as part of their routine care.
Key exclusion criteria (9 listed)
- diabetes mellitus
- prior history of neuropathy or symptoms of numbness or peripheral pain, or prior neurotoxic chemotherapy.
- current symptoms of numbness and neuropathic pain
- treatment for bipolar disease
- treatment or concomitant use of common medications used to treat neuropathic pain, such as amitriptyline, gabapentin, pregabalin, duloxetine, for any indication
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 |
|---|---|---|
| Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancerQuantitative measures that include additional aspects of peripheral neuropathy, such as pain, thermal allodynia, numbness and tingling are needed. We propose to evaluate several pharmacodynamics biomarkers in patients before and during chemotherapy: changes in nerve conduction velocity and amplitude, quantitative sensory testing (QST), computer based cognitive assessment, and rate of drop-out from treatment. The tests from this list that best correlate with decreased CIPN would be added to EORTC QLQ-CIPN20 scores and will provide an early indication of CIPN and/or CICI. | Diagnostic test | patients with stage I-III breast cancer |
Primary outcome
Verbal Memory Test
Time frame: 20 minutes
The phrase "Shopping List Learning" is displayed on screen. The pre-task on-screen instructions tell the test supervisor to start this task with the screen facing the supervisor so that the subject cannot see the screen. There are 3 initial rounds of this test. In the first round, the subject is told by the test supervisor: "In this task, I am going to read you a shopping list. I would like you to remember as many items from this list as possible.Total number of correct responses made in remembering the 16 word list on three consecutive learning trials. (Higher score = better performance)
Information processing psychomotor function
Time frame: 20 minutes
The pre-task on-screen instructions ask: "Has the card turned over?" The test supervisor reads the full instructions to the subject from the test supervisor script. To begin the task, a playing card is presented in the center of the screen. The card will flip over so it is face up. As soon as it does, the subject must press the "Yes" key. The card will go to the back of the pack and the subject must press the "Yes" key as soon as the next card flips over and so on. The subject will practice until they reach the required number of responses, or until the practice period expires. Then, on screen instructions for the real test are presented. The test supervisor or subject must press the "Enter" key to begin the real test. Speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score = better performance
Identification
Time frame: 20 minutes
To begin the task, the test supervisor or subject must press the "Enter" key. A playing card is presented in the center of the screen. The card will flip over so it is face up. As soon as it does this the subject must decide whether the card is red or not. If it is red they should press "Yes", if it is not red they should press "No". The subject will practice until they reach the required number of responses, or until the practice period expires. Then, on screen instructions for the real test are presented. The subject should be encouraged to work as quickly as they can and be as accurate as they can. Low score = better performance.
Visual Working Memory
Time frame: 20 minutes
The pre-task on-screen instructions ask: "Is the previous card the same?" The test supervisor will read full instructions to the subject from the test supervisor script. To begin the task,a playing card is presented in the center of the screen. As soon as it does the subject must decide whether or not the card is the same as the previous one. As this is the first card in this task, the first answer is always "No". Each time a card is revealed, the subject must decide whether the card presented is the same as the one immediately presented previously, and respond by pressing the "Yes" or "No" key. The subject should be encouraged to work as quickly as they can and be as accurate as they can. Speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score = better performance
Visual Learning Memory
Time frame: 20 minutes
The pre-task on-screen instructions ask: "Have you seen this card before in this task?" The test supervisor will read full instructions to the subject from the test supervisor script. To begin the task, the test supervisor or subject must press the "Enter" key. A playing card is presented in the center of the screen. As soon as it does the subject must decide whether or not the same card has been seen before in this task. Therefore, the first answer is always "No". Each time a card is revealed, the subject must decide whether they have been shown that card before in this task and respond by pressing the "Yes" or "No" key. The subject should be encouraged to work as quickly as they can and be as accurate as they can. Accuracy of performance; arcsine transformation of the proportion of correct responses. Higher score = better performance
Verbal Memory Test - Delay
Time frame: 20 minutes
The test supervisor presses the "ENTER" key to begin and instructs the subject "Tell me as many of the items on the shopping list that you learned earlier as you can remember now." They then note all of the items recalled by the subject by clicking/touching the corresponding button on screen with the stylus or mouse. Total number of correct responses made in recalling the 16 words learned previously after a delay. (Higher score = better performance
3 secondary outcomes
To correlate neuronal calcium sensor 1 (NCS1) levels with development of chemotherapy-induced peripheral neuropathy (CIPN) and/or chemotherapy-induced cognitive impairment (CICI) in human patients.
Time frame: baseline
To correlate NCS1 levels with development of CIPN and/or CICI in human patients.
Time frame: 6 weeks
To correlate NCS1 levels with development of CIPN and/or CICI in human patients.
Time frame: 12 weeks
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 3 May 2021.
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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.
Barbara Ehrlich, PhD principal investigator
Yale 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 Breast Cancer and Chemotherapy Induced Peripheral Neuropathy, run by Yale University 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 1 inclusion and 9 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 3 May 2021. 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?
Verbal Memory Test (time frame: 20 minutes). The study lists 6 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 3 May 2021.