Phase 2
N=22
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study
Chemo Brain · Chemotherapy-related Cognitive Impairment · Chemo Fog · Breast Cancer · Chemobrain
Bottom Line
View on ClinicalTrials.gov: NCT02312934 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale — 7.00; 11.55; 16.80; 16.64 units on a scale — p==0.41
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Transdermal nicotine (Drug); Placebo Transdermal Patch (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale |
7.00; 11.55; 16.80; 16.64; 11.20; 16.55 | =0.41 |
| SECONDARY Conners Continuous Performance Test |
0.0127; -0.0318; 0.01; -0.0355; -0.0185; -0.0236 | 0.79 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02312934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.