Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients

Yale University

Status: Completed

Conditions: Chemotherapy Induced Peripheral Neuropathy; Breast Cancer; Paclitaxel Induced Neuropathy

Treatments: Diagnostic Test: Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03872141

2000020709

Details and patient eligibility

About

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).

Full 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).

Enrollment: 13 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• 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 design

13 participants in 1 patient group

patients with stage I-III breast cancer

Description:

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.

Treatment:

Diagnostic Test: Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer