Clinical trial NCT03872141: Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients
Official title: Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Chemotherapy Induced Peripheral Neuropathy
Paclitaxel Induced Neuropathy
Keywords: neuropathy
taxane
docetaxel
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Verbal Memory Test
timeFrame: 20 minutes
measure: Information processing psychomotor function
timeFrame: 20 minutes
measure: Identification
timeFrame: 20 minutes
measure: Visual Working Memory
timeFrame: 20 minutes
measure: Visual Learning Memory
timeFrame: 20 minutes
measure: Verbal Memory Test - Delay
timeFrame: 20 minutes
Secondary outcomes:
measure: 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.
timeFrame: baseline
measure: To correlate NCS1 levels with development of CIPN and/or CICI in human patients.
timeFrame: 6 weeks
measure: To correlate NCS1 levels with development of CIPN and/or CICI in human patients.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Smilow Cancer Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Barbara Ehrlich, PhD
role: PRINCIPAL_INVESTIGATOR
References: