Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN)
研究概览
简要总结
Assess the efficacy of short-term nicotine transdermal patch administration for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) in cancer stable patients or patients in remission.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed peripheral sensory neuropathy defined as:
- •Greater than Grade 1 peripheral sensory neuropathy using the CTCAE v5.0 grading scale
- •Grade 1 Asymptomatic
- •Grade 2 Moderate symptoms; limiting instrumental activities of daily living (ADL)
- •Grade 3 Severe symptoms; limiting self-care ADL
- •Grade 4 Life-threatening consequences; urgent intervention indicated
- •Have a baseline chemotherapy-induced peripheral neuropathy (CIPN) patient reported outcome (PRO) total sensory score ≥ 24.3 on a 19 to 76 scale using the European Organization for Research and Treatment of Cancer Quality of Life-CIPN20 Questionnaire (EORTC QLQ-CIPN-20)
- •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
- •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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Not currently receiving any chemotherapy
- •Have previously received platinum- and/or taxane-based chemotherapy treatments and have persistent pain at least 3 months after completion of treatments.
- •Willing and able to comply with study procedures and visit schedule.
- •Willing to abstain from all tobacco/nicotine product use during study treatment and 30-day follow-up period.
- •Ability to self-apply or have the patch applied at home daily.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •History of pre-existing peripheral sensory neuropathies related to the following:
- •Autoimmune disease
- •B12/folate deficiency
- •Diabetes Mellitus
- •Human immunodeficiency virus (HIV)
- •Hyper/hypothyroidism
- •Monoclonal gammopathy of undetermined significance or multiple myeloma
- •History of receiving other types of neurotoxic chemotherapy drugs (eg, vinca alkaloids, bortezomib, thalidomide)
- •Current or prior pheochromocytoma
- •History of or active or clinically significant cardiac disease including any of the following:
- •Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment
- •Myocardial infarction diagnosed within 6 months prior to initiating study treatment
- •Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
- •New York Heart Association (NYHA) class III or IV congestive heart failure
- •Poorly controlled high or low blood pressure defined as:
- •Systolic blood pressure (SBP) ≥ 140; Diastolic blood pressure (DBP) ≥ 90
- •SBP ≤ 90; DBP ≤ 60
- •Regular use of the following medications:
- •Varenicline
- •Bupropion (ie, bupropion hydrochloride sustained release)
- •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.
- •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
研究组 & 干预措施
Nicotine Transdermal Patch Administration
Each patient will complete two 14-day treatment conditions, for 7 mg nicotine transdermal patch administration with a washout period in between (≥ 14 days and up to 21 days), then 14 mg nicotine transdermal patch administration (14 days).
干预措施: Nicotine Transdermal Patch (Drug)
结局指标
主要结局
Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN)
时间窗: 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 European Organization for Research and Treatment of Cancer Quality of Life-cancer induced peripheral neuropathy (CIPN20) Questionnaire (EORTC QLQ-CIPN-20) (eg, an improvement in the patients quality of life by one grade). The QLQ-CIPN20 numerical score has a range of 19-76, in which lower scores indicate less symptoms and a better quality of life.
次要结局
- Efficacy of Pain-related Changes and Degree of Functional Interference in the Treatment of CIPN(79 Days)
- Number of Participants at Risk and Affected by Adverse Events (AEs) Related to the Transdermal Nicotine Patch.(79 Days)