Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer

Indiana University

Status: Completed

Conditions: Peripheral Neuropathy

Treatments: Procedure: Axon Reflexes; Procedure: Self-Reported Signs & Symptoms of CIPN; Procedure: Axon Flares

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02549534

1502603664

F31NR01521201A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 29 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

29 participants in 2 patient groups

Women with Breast Cancer (WBC)

Description:

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.

Treatment:

Procedure: Self-Reported Signs & Symptoms of CIPN

Procedure: Axon Reflexes

Procedure: Axon Flares

Healthy Female Controls (HCs)

Description:

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.

Treatment:

Procedure: Self-Reported Signs & Symptoms of CIPN

Procedure: Axon Reflexes

Procedure: Axon Flares