Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Chemo Brain, Chemotherapy-related Cognitive Impairment, Chemo Fog, Breast Cancer, Chemobrain

In brief

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.

Key facts

Study ID

NCT02312934

Run by

Vanderbilt University Medical Center

People needed

22

Starts

2015-08-01

Expected to finish

2018-05-01

Last updated by the study team

2020-01-21

Who can join

Age: 35 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Center for Cognitive Medicine at Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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