Clinical trial NCT02549534: Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
Official title: Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Neuropathy
Keywords: 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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Midwest Nursing Research Society (MNRS)
name: Council for the Advancement of Nursing Science (CANS)
name: Indiana Center for Vascular Biology & Medicine (ICVBM)
name: Indiana University School of Medicine
First posted: 2015-09-15
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women with breast cancer (WBC) and healthy female controls (HCs)

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria for Women with Breast Cancer:

* 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;

Inclusion Criteria for Healthy Controls:

* 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).

Primary outcomes:
measure: Differences in the mean size of axon reflexes between healthy women and women with breast cancer BEFORE starting Taxol.
timeFrame: Day 1 (before participant's 1st Taxol infusion).
measure: Differences in the mean size of axon reflexes between healthy women and women with breast cancer DURING Taxol therapy.
timeFrame: Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
measure: Differences in the mean size of axon reflexes OVER TIME for women with breast during the initial six weeks of Taxol therapy.
timeFrame: Day 1 (before participant's 1st Taxol infusion), day 14 (week two of Taxol therapy) and day 42 (week six of Taxol therapy).
measure: Differences in the mean size of axon reflexes between healthy female controls OVER TIME the six-week study period.
timeFrame: Day 1 (before participant's 1st Taxol infusion), Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
Secondary outcomes:
measure: Differences in the mean size of heat-evoked axon flares between healthy women and women with breast cancer BEFORE starting Taxol therapy.
timeFrame: Day 1 (before participant's 1st Taxol infusion).
measure: Differences in the mean size of heat-evoked axon flares between healthy women and women with breast cancer DURING six weeks of study visits.
timeFrame: Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
measure: Differences in the mean size of heat-evoked axon flares between women with breast cancer DURING their initial six weeks of Taxol therapy.
timeFrame: Day 1 (before participant's 1st Taxol infusion), Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
measure: Differences in the size of heat-evoked axon flares for healthy women during the six-week study period.
timeFrame: Day 1 (before participant's 1st Taxol infusion), Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
Other outcomes:
measure: Correlations between the size of axon reflexes (expressed in %CVCmax) and the average modified-Total Neuropathy (m-TNS) score for women with breast cancer AT EACH TIMEPOINT during Taxol Therapy.
timeFrame: Day 1 (before participant's 1st Taxol infusion), Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
measure: Correlation between the size of axon reflexes (expressed in %CVCmax) and the average modified Total Neuropathy Score (TNS) for healthy women AT EACH TIMEPOINT during the six-week study period.
timeFrame: Day 1 (before participant's 1st Taxol infusion), Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
measure: Correlation between (a) the size of heat-evoked axon flares (in cm2) and (b) the average modified-Total Neuropathy Score (mTNS) for women with breast cancer AT EACH TIMEPOINT during Taxol Therapy.
timeFrame: Day 1 (before participant's 1st Taxol infusion), Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
measure: Correlation between (a) the size of heat-evoked axon flares (in cm2) and (b) the average modified-Total Neuropathy Score (mTNS) for healthy women AT EACH TIMEPOINT during Taxol Therapy.
timeFrame: Day 1 (before participant's 1st Taxol infusion), Day 14 (week two of Taxol therapy) and Day 42 (week six of Taxol therapy).
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center (IUSCC)
state: Indiana
city: Indianapolis
country: United States
facility: Syndney & Lois Eskenazi Health Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Victoria L. Champion, PhD,RN,FAAN
role: PRINCIPAL_INVESTIGATOR
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