Status:
COMPLETED
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Chemo Brain
Chemotherapy-related Cognitive Impairment
Eligibility:
FEMALE
35-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the use of a nicotine patch as a treatment for problems with attention, learning and memory in breast cancer patients who are 1-5 years post chemotherapy.
Detailed Description
Studies have suggested that chemotherapy treatment for breast cancer may change the way the brain functions. As a result, patients who receive chemotherapy for breast cancer may experience problems wi...
Eligibility Criteria
Inclusion
- All participants will:
- Be between 35 and 80 years of age,
- Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer,
- Have undergone treatment with systemic chemotherapy within the last 1-5 years,
- Endorse persistent CRCI subjective complaints,
- Be non-smokers (no nicotine use within the last 5 years),
- Have no active cardiac, neurologic, or psychiatric illness, and
- Fluent in and able to read English.
Exclusion
- Participants will be excluded for:
- Any active neurologic and/or psychiatric disease, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities,
- Current major depression or another major psychiatric disorder as described in DSM-5 (use of CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months),
- Any history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria),
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:
- History of myocardial infarction in the past year or unstable, severe cardiovascular disease including angina or CHF with symptoms at rest, or clinically significant abnormalities on the ECG
- Clinically significant and/or unstable pulmonary, gastrointestinal, hepatic, or renal disease
- Insulin-requiring diabetes or uncontrolled diabetes mellitus,
- Uncontrolled hypertension (systolic BP\> 170 or diastolic BP\> 100), 5. Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening, and 6. Use of any drugs with pro-cholinergic properties (e.g. donepezil).
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02312934
Start Date
August 1 2015
End Date
May 1 2018
Last Update
January 21 2020
Active Locations (1)
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1
Center for Cognitive Medicine at Vanderbilt University
Nashville, Tennessee, United States, 37212