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

NCT ID: NCT02312934

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-05-31

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 with their attention, learning, and memory that they did not have before receiving chemotherapy. The investigators have found that nicotine treatment can help other types of patients with similar difficulties with attention, learning, and memory. Nicotine is a naturally occurring substance found in tobacco and is known to interact with nerve cells in the brain that are important for functions like learning and memory, and has been studied in a number of disorders. This study is designed to test whether nicotine treatment is helpful for learning and memory problems after chemotherapy for breast cancer.

This study will be a randomized, placebo-controlled pilot study to evaluate the effect of transdermal nicotine to 1) reduce subjective complaints and 2) enhance cognitive performance on laboratory measures of cognitive performance in breast cancer patients with persistent chemotherapy-related cognitive impairment (CRCI), a condition also known as "chemo brain." Participants will be randomized to either placebo or active compound (50/50) for the 6-week treatment portion of the study. Participants will be assessed before, during, and at the end of treatment. At the end of the 8-week study, participants will have the option to take part in the open-label portion of the study for an additional 6 weeks.

Conditions

Chemo Brain; Chemotherapy-related Cognitive Impairment; Chemo Fog; Breast Cancer; Chemobrain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Transdermal Nicotine

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

Group Type: EXPERIMENTAL

Transdermal nicotine

Intervention Type: DRUG

Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo Transdermal Patch

Intervention Type: OTHER

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Interventions

Transdermal nicotine

Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.

Intervention Type: DRUG

Placebo Transdermal Patch

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Paul Newhouse

Professor of Psychiatry, Pharmacology, and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul A Newhouse, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Center for Cognitive Medicine at Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

141584

Identifier Type: -

Identifier Source: org_study_id