Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
NCT ID: NCT02549534
Last Updated: 2017-10-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
29 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-09-30
Study Completion Date
2016-07-31
Brief Summary
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Purpose: The purpose of the study is to test a new way of measuring nerve damage in women with breast cancer receiving chemotherapy drug paclitaxel (Taxol).
Detailed Description
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Purpose: The study has four aims;
* The primary aim of the study is to determine whether women who are receiving either weekly Taxol (80-100 mg/m2) or bi-weekly Taxol (i.e.,dose-dense; 175 mg/m2) show deficits in axon-reflex mediated vasodilation (AMV) over the course of six weeks of Taxol therapy similar to those that have been reported in patients with diabetic and genetically-inherited neuropathies.
* The second aim of the study is to determine whether women who are receiving either weekly or dose-dense Taxol develop changes in AMV before developing signs \& symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in a way that supports using changes in AMV as an early detection method for small-fiber CIPN.
* A third (exploratory) aim of the study is to determine whether any changes in AMV detected during the study are significantly correlated with self-reported CIPN in a way that would support using changes in AMV as a confirmatory marker for CIPN.
* A final (exploratory) aim of the study is to describe the size of axon reflexes and axon flares in women receiving weekly Taxol before they start their pre-Taxol anthracycline \& cyclophosphamide (AC) therapy.
* The primary aim of the study is to determine whether women who are receiving either weekly Taxol (80-100 mg/m2) or bi-weekly Taxol (i.e.,dose-dense; 175 mg/m2) show deficits in axon-reflex mediated vasodilation (AMV) over the course of six weeks of Taxol therapy similar to those that have been reported in patients with diabetic and genetically-inherited neuropathies.
* The second aim of the study is to determine whether women who are receiving either weekly or dose-dense Taxol develop changes in AMV before developing signs \& symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in a way that supports using changes in AMV as an early detection method for small-fiber CIPN.
* A third (exploratory) aim of the study is to determine whether any changes in AMV detected during the study are significantly correlated with self-reported CIPN in a way that would support using changes in AMV as a confirmatory marker for CIPN.
* A final (exploratory) aim of the study is to describe the size of axon reflexes and axon flares in women receiving weekly Taxol before they start their pre-Taxol anthracycline \& cyclophosphamide (AC) therapy.
Conditions
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Peripheral Neuropathy
Keywords
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Taxane
Neuropathy
Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Breast Cancer
Local skin heating
Axon reflex
Axon flare
Total Neuropathy Score (TNS)
Laser Doppler Flowmetry (LDF)
Laser Speckle Contrast Imaging (LSCI)
Full-field laser perfusion imaging (FLPI)
Paclitaxel
Taxol
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Women with Breast Cancer (WBC)
Defined as women who:
* Are 18 to 85 years old at the time of enrollment;
* Have histologically-confirmed, first-time, non-metastatic breast cancer (Stage I-IIIB);
* Have no history of neurotoxic chemotherapy or radiation treatment at the time of enrollment;
* Will be receiving weekly paclitaxel (Taxol® or generic paclitaxel), 80-100mg/m2, or bi-weekly (i.e., dose-dense) Taxol, 175 mg/m2, as a part of their treatment regimen OR
* Will be receiving an anthracycline and cyclophosphamide (AC) therapy followed by weekly or bi-weekly (i.e., dose-dense; 175 mg/m2) paclitaxel (Taxol® or generic paclitaxel, 80-100mg/m2);
* Are willing to participate in up to four study sessions.
Axon Reflexes
Intervention Type
PROCEDURE
\*Axon reflexes will be evoked in the palmar surface of the right great toe using local skin heating with a 0.33 cm2 heat probe using the following protocol:
* Baseline: Heating the skin of the toe for a minimum of 5 minutes at 33\*C.
* Heat Ramp: Increasing the heat in the heat probe to 42\*C at approx. 0.1\*C/10 sec.
* Skin Heating: Heating the skin of the toe for 30 minutes 42\*C.
* Heat Ramp: Increasing the heat in the heat probe to 44\*C at 0.1\*C/10 sec..
* Skin Heating: Heating the skin for an additional 5 minutes at 44\*C.
The size of the axon reflex during this skin heating protocol will be imaged using Laser Doppler Flowmetry (LDF). In the case that participants develop CIPN on their left side only, the left toe will be substituted.
Axon Flares
Intervention Type
PROCEDURE
Axon flares will be generated on the palmar surface of the right great toe using the same local skin heating protocol described above, and imaged using a laser speckle contrast imager (LSCI) (also known as full-field laser perfusion imager, or FLPI).
Self-Reported Signs & Symptoms of CIPN
Intervention Type
PROCEDURE
Self-reported signs \& symptoms of CIPN such as the presence and location of (1) tingling, (2) numbness, and (3) neuropathic pain, along with information about (4) deficits in vibration thresholds, and (5) loss of deep tendon reflexes will be assessed at each study visit using the 5-item, modified Total Neuropathy Score (mTNS).
Healthy Female Controls (HCs)
Defined as women who:
* Are 18 to 85 years old at the time of study enrollment;
* Can read, write, and understand English,
* Are willing to participate in three planned study sessions.
Axon Reflexes
Intervention Type
PROCEDURE
\*Axon reflexes will be evoked in the palmar surface of the right great toe using local skin heating with a 0.33 cm2 heat probe using the following protocol:
* Baseline: Heating the skin of the toe for a minimum of 5 minutes at 33\*C.
* Heat Ramp: Increasing the heat in the heat probe to 42\*C at approx. 0.1\*C/10 sec.
* Skin Heating: Heating the skin of the toe for 30 minutes 42\*C.
* Heat Ramp: Increasing the heat in the heat probe to 44\*C at 0.1\*C/10 sec..
* Skin Heating: Heating the skin for an additional 5 minutes at 44\*C.
The size of the axon reflex during this skin heating protocol will be imaged using Laser Doppler Flowmetry (LDF). In the case that participants develop CIPN on their left side only, the left toe will be substituted.
Axon Flares
Intervention Type
PROCEDURE
Axon flares will be generated on the palmar surface of the right great toe using the same local skin heating protocol described above, and imaged using a laser speckle contrast imager (LSCI) (also known as full-field laser perfusion imager, or FLPI).
Self-Reported Signs & Symptoms of CIPN
Intervention Type
PROCEDURE
Self-reported signs \& symptoms of CIPN such as the presence and location of (1) tingling, (2) numbness, and (3) neuropathic pain, along with information about (4) deficits in vibration thresholds, and (5) loss of deep tendon reflexes will be assessed at each study visit using the 5-item, modified Total Neuropathy Score (mTNS).
Interventions
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Axon Reflexes
\*Axon reflexes will be evoked in the palmar surface of the right great toe using local skin heating with a 0.33 cm2 heat probe using the following protocol:
* Baseline: Heating the skin of the toe for a minimum of 5 minutes at 33\*C.
* Heat Ramp: Increasing the heat in the heat probe to 42\*C at approx. 0.1\*C/10 sec.
* Skin Heating: Heating the skin of the toe for 30 minutes 42\*C.
* Heat Ramp: Increasing the heat in the heat probe to 44\*C at 0.1\*C/10 sec..
* Skin Heating: Heating the skin for an additional 5 minutes at 44\*C.
The size of the axon reflex during this skin heating protocol will be imaged using Laser Doppler Flowmetry (LDF). In the case that participants develop CIPN on their left side only, the left toe will be substituted.
Intervention Type
PROCEDURE
Axon Flares
Axon flares will be generated on the palmar surface of the right great toe using the same local skin heating protocol described above, and imaged using a laser speckle contrast imager (LSCI) (also known as full-field laser perfusion imager, or FLPI).
Intervention Type
PROCEDURE
Self-Reported Signs & Symptoms of CIPN
Self-reported signs \& symptoms of CIPN such as the presence and location of (1) tingling, (2) numbness, and (3) neuropathic pain, along with information about (4) deficits in vibration thresholds, and (5) loss of deep tendon reflexes will be assessed at each study visit using the 5-item, modified Total Neuropathy Score (mTNS).
Intervention Type
PROCEDURE
Other Intervention Names
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LDIflare, Heat-Evoked Axon Flare
Eligibility Criteria
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Inclusion Criteria
* Age 18-85
* Able to read, write, and understand English
* Diagnosed with histologically-confirmed, first-time, non-metastatic breast cancer (stage I-IIIB)
* No prior exposure to neurotoxic chemotherapy or radiation at the time of enrollment,
* Will be receiving weekly paclitaxel (Taxol® or generic paclitaxel, 80- 100mg/m2) or bi-weekly Taxol (i.e., dose-dense; 175 mg/m2) as a part of their cancer treatment regimen OR
* Will be receiving an anthracycline and cyclophosphamide (AC) followed by weekly paclitaxel (Taxol® or generic paclitaxel, 80-100mg/m2) or bi-weekly Taxol (i.e., dose-dense; 175 mg/m2) as a part of their cancer treatment regimen;
* Aged 18-85
* Can read, write, and understand English
* Able to read, write, and understand English
* Diagnosed with histologically-confirmed, first-time, non-metastatic breast cancer (stage I-IIIB)
* No prior exposure to neurotoxic chemotherapy or radiation at the time of enrollment,
* Will be receiving weekly paclitaxel (Taxol® or generic paclitaxel, 80- 100mg/m2) or bi-weekly Taxol (i.e., dose-dense; 175 mg/m2) as a part of their cancer treatment regimen OR
* Will be receiving an anthracycline and cyclophosphamide (AC) followed by weekly paclitaxel (Taxol® or generic paclitaxel, 80-100mg/m2) or bi-weekly Taxol (i.e., dose-dense; 175 mg/m2) as a part of their cancer treatment regimen;
* Aged 18-85
* Can read, write, and understand English
Exclusion Criteria
* A history of cardiovascular disease, hypertension, or peripheral arterial/vascular disease;
* Current use of (1) medications/supplements to control blood pressure (e.g. beta-blockers, nitrates, calcium channel blockers, Phosphodiesterase-5 (PGE5) inhibitors) or (2) the use of statins for cholesterol;
* Suspected or diagnosed diabetes (with the exception of gestational diabetes);
* Pre-existing neuropathy, neuropathic pain, or nerve injury;
* Pain or significant arthritis in the toes of either foot;
* Current skin disease or fungal infection of the feet;
* Significant damage or deformity to the feet that would alter blood flow or make it impossible to measure/interpret findings;
* Diagnosed or suspected vasospastic disease such as Raynaud's syndrome;
* Current use of tobacco/tobacco-containing products;
* Diagnosis of restless leg syndrome or other movement disorders that would prevent accurate data from being able to be collected.
In-Study Restrictions:
* No caffeine- or alcohol-containing products for 12 hours prior to their study visit;
* No food for at least one hour prior to blood flow monitoring;
* No non-steroidal anti-inflammatory drugs (NSAIDS) for 24 hours prior to study visits unless directed by a physician to do so.
(Note: These restrictions are designed to improve the rigor and quality of the data, but non-compliance will not be grounds for study exclusion; adherence to these restrictions will be monitored during self-report).
* Current use of (1) medications/supplements to control blood pressure (e.g. beta-blockers, nitrates, calcium channel blockers, Phosphodiesterase-5 (PGE5) inhibitors) or (2) the use of statins for cholesterol;
* Suspected or diagnosed diabetes (with the exception of gestational diabetes);
* Pre-existing neuropathy, neuropathic pain, or nerve injury;
* Pain or significant arthritis in the toes of either foot;
* Current skin disease or fungal infection of the feet;
* Significant damage or deformity to the feet that would alter blood flow or make it impossible to measure/interpret findings;
* Diagnosed or suspected vasospastic disease such as Raynaud's syndrome;
* Current use of tobacco/tobacco-containing products;
* Diagnosis of restless leg syndrome or other movement disorders that would prevent accurate data from being able to be collected.
In-Study Restrictions:
* No caffeine- or alcohol-containing products for 12 hours prior to their study visit;
* No food for at least one hour prior to blood flow monitoring;
* No non-steroidal anti-inflammatory drugs (NSAIDS) for 24 hours prior to study visits unless directed by a physician to do so.
(Note: These restrictions are designed to improve the rigor and quality of the data, but non-compliance will not be grounds for study exclusion; adherence to these restrictions will be monitored during self-report).
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Sponsor Role
collaborator
Midwest Nursing Research Society (MNRS)
UNKNOWN
Sponsor Role
collaborator
Council for the Advancement of Nursing Science (CANS)
UNKNOWN
Sponsor Role
collaborator
Indiana Center for Vascular Biology & Medicine (ICVBM)
UNKNOWN
Sponsor Role
collaborator
Indiana University School of Medicine
OTHER
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
lead
Responsible Party
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Victoria L. Champion
Distinguished Professor of Nursing; Edward and Sarah Stam Cullipher Endowed Chair; Associate Director of Cancer Control and Population Sciences, Indiana University Simon Cancer Center (IUSCC)
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Victoria L. Champion, PhD,RN,FAAN
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University Melvin and Bren Simon Cancer Center (IUSCC)
Indianapolis, Indiana, United States
Site Status
Syndney & Lois Eskenazi Health Center
Indianapolis, Indiana, United States
Site Status
Countries
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United States
References
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Related Links
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https://scholarworks.iupui.edu/bitstream/handle/1805/2606/Thesis_Neilia_Gr
Gracias N. Paclitaxel alters the function of the small diameter sensory neurons. \[Dissertation\]. United States--Indiana, Indiana University; 2011.
Other Identifiers
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F31NR01521201A1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1502603664
Identifier Type: -
Identifier Source: org_study_id