Clinical trial · Interventional
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study
NCT02312934CI-TRIAL-00042879completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemobrain | — | UNRESOLVED | — |
| Chemo Brain | — | UNRESOLVED | — |
| Chemo Fog | — | UNRESOLVED | — |
| Chemotherapy-related Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Transdermal Patch | Other | — | UNRESOLVED |
| Transdermal nicotine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transdermal Nicotine
- description
- Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows: Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal
- interventionNames
- Drug: Transdermal nicotine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm. Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal
- interventionNames
- Other: Placebo Transdermal Patch
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * All participants will: 1. Be between 35 and 80 years of age, 2. Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer, 3. Have undergone treatment with systemic chemotherapy within the last 1-5 years, 4. Endorse persistent CRCI subjective complaints, 5. Be non-smokers (no nicotine use within the last 5 years), 6. Have no active cardiac, neurologic, or psychiatric illness, and 7. Fluent in and able to read English. Exclusion Criteria: * Participants will be excluded for: 1. Any active neurologic and/or psychiatric disease, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities, 2. 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), 3. Any history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria), 4. 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).
References
Publications (0)
Data not yet available
No reference posted for this study.