Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Study Details
Study Description
Brief Summary
Assess the efficacy of short-term nicotine transdermal patch administration for the treatment of CIPN in cancer stable patients or patients in remission.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This phase 2 study will test the efficacy of short-term transdermal nicotine transdermal patch administration in patients who have been diagnosed with CIPN. The study will follow an open-label, crossover within-subjects clinical trial design with nicotine transdermal patch.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nicotine Transdermal Patch Administration Each patient will complete two 14-day treatment conditions, one each for 7 mg and 14 mg nicotine transdermal patch administration with a washout period in between (≥ 14 days and up to 21 days). |
Drug: Nicotine Transdermal Patch
Nicotine Treatment Condition
|
Outcome Measures
Primary Outcome Measures
- Efficacy of short-term nicotine transdermal patch administration in the treatment of cancer induced peripheral neuropathy (CIPN) [79 Days]
To assess the efficacy, of the nicotine transdermal patch administration in the treatment of CIPN in patients whose cancer is stable or in remission as defined by a ≥ 2.7 point decrease in the total sensory score of the EORTC QLQ-CIPN-20 (eg, an improvement in the patients quality of life by one grade)
Secondary Outcome Measures
- Efficacy of pain-related changes and degree of functional interference in the treatment of CIPN [79 Days]
To assess the efficacy of short-term nicotine transdermal patch administration in the treatment of CIPN in patients whose cancer is stable or in remission by assessing changes in the degree of pain-related functional interference measured by the BPI-SF interference score.
- Number of Participants at Risk and Affected by Adverse Events (AEs) related to the transdermal nicotine patch. [79 Days]
To assess the AEs profile of nicotine transdermal patch administration for the treatment of CIPN in patients whose cancer is stable or in remission. The Adverse events (AEs) are reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version (CTCAE v 5.0)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinically diagnosed peripheral sensory neuropathy defined as:
-
Greater than Grade 1 peripheral sensory neuropathy using the CTCAE v5.0 grading scale
-
Grade 1 Asymptomatic
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Grade 2 Moderate symptoms; limiting instrumental activities of daily living (ADL)
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Grade 3 Severe symptoms; limiting self-care ADL
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Grade 4 Life-threatening consequences; urgent intervention indicated
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Have a baseline CIPN PRO total sensory score ≥ 24.3 on a 19 to 76 scale using the EORTC QLQ-CIPN-20 questionnaire
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Have a CIPN-related neuropathic pain score ≥ 4 on a 0 to 10 scale using the Brief Pain Inventory-Short Form (BPI-SF) item 5
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Will not have used any nicotine or tobacco products (eg, cigarettes, electronic cigarettes, smokeless tobacco, or other nicotine replacement therapies) within 14 days prior to study treatment start date
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Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
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Not currently receiving any chemotherapy
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Have previously received platinum- and/or taxane-based chemotherapy treatments and have persistent pain at least 3 months after completion of treatments.
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Willing and able to comply with study procedures and visit schedule.
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Willing to abstain from all tobacco/nicotine product use during study treatment and 30-day follow-up period.
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Ability to self-apply or have the patch applied at home daily.
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Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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History of pre-existing peripheral sensory neuropathies related to the following:
-
Autoimmune disease
-
B12/folate deficiency
-
Diabetes Mellitus
-
Human immunodeficiency virus (HIV)
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Hyper/hypothyroidism
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Monoclonal gammopathy of undetermined significance or multiple myeloma
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History of receiving other types of neurotoxic chemotherapy drugs (eg, vinca alkaloids, bortezomib, thalidomide)
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Current or prior pheochromocytoma
-
History of or active or clinically significant cardiac disease including any of the following:
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Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment
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Myocardial infarction diagnosed within 6 months prior to initiating study treatment
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Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
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New York Heart Association (NYHA) class III or IV congestive heart failure
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Poorly controlled high or low blood pressure defined as:
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SBP ≥ 140; DBP ≥ 90
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SBP ≤ 90; DBP ≤ 60
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Regular use of the following medications:
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Varenicline
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Bupropion (ie, bupropion hydrochloride sustained release)
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Women will be excluded if they are breastfeeding or are pregnant (by urinalysis) within 14 days prior to the start of nicotine transdermal patch administration.
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Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
| 2 | VCU Community Memorial Healthcenter | Richmond | Virginia | United States | 23950 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Zhi-Jian Chen, MD, PhD, Massey Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-16-12518