Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Placebo-Controlled Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- Change in Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline
研究概览
简要总结
This clinical trial compares topical cannabidiol to placebo in improving chemotherapy-induced peripheral neuropathy, or painful sensations in your hands or feet due to chemotherapy. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Peripheral neuropathy caused by chemotherapy is called chemotherapy-induced peripheral neuropathy (CIPN). CIPN is commonly seen in patients receiving certain chemotherapy medications and is hard to treat. Medications commonly used to treat CIPN have limited benefits and may cause significant side effects. A small report showed that topical cannabidiol may help treat neuropathy in patients with diabetes. This study is being done to determine if cannabidiol cream can help improve the symptoms of CIPN.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate whether topical cannabidiol (CBD) improves CIPN, compared to placebo.
II. To evaluate side effects from topical CBD cream use, compared to placebo.
SECONDARY OBJECTIVES:
I. Other measures of neuropathy as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN20 motor subscale, the EORTC QLQ CIPN20 autonomic scale, and the total Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age >= 18 years
- •English speaking
- •Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy
- •At least 4 out of 10 severity of neuropathy pain and/or tingling
- •Stable for at least 7 days prior to registration on medications for neuropathy, if any are being used
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
- •NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •Able to provide written informed consent
- •Ability to complete questionnaire(s) by themselves or with assistance
- •No evidence of residual cancer
- •Platelet count > 100,000/mm^3 (following completion of chemotherapy)
- •Absolute neutrophil count (ANC) >= 1,000/mm^3 (following completion of chemotherapy)
- •Hemoglobin > 11 g/dL (following completion of chemotherapy)
- •Serum transaminase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) =< 1.2 x upper limit of normal (ULN) (following completion of chemotherapy)
- •Alkaline phosphatase =< 1.2 x ULN (following completion of chemotherapy)
- •Serum creatinine =< 1.2 x ULN (following completion of chemotherapy)
排除标准
- •Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- •Pregnant persons
- •Nursing persons
- •Persons of childbearing potential who are unwilling to employ adequate contraception
- •Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy)
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN
- •Currently on chemotherapy or received chemotherapy treatment within the prior 3 months
- •Use of other cannabis products within 30 days prior to registration
- •History of allergy to cannabis products
研究组 & 干预措施
Arm I (cannabidiol, placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
干预措施: Quality-of-Life Assessment (Other)
Arm I (cannabidiol, placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
干预措施: Cannabidiol (Drug)
Arm I (cannabidiol, placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
干预措施: Placebo Administration (Drug)
Arm I (cannabidiol, placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
干预措施: Questionnaire Administration (Other)
Arm II (placebo, cannabidiol)
Patients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.
干预措施: Cannabidiol (Drug)
Arm II (placebo, cannabidiol)
Patients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.
干预措施: Placebo Administration (Drug)
Arm II (placebo, cannabidiol)
Patients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.
干预措施: Quality-of-Life Assessment (Other)
Arm II (placebo, cannabidiol)
Patients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline
时间窗: Week 1, week 2, week 3, and week 4
CIPN will be measured by the sensory subscale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 which is composed of 9 individual items. Each item is scored on a 1-to-4 scale, where 1 means "not at all" and 4 means "very much." Higher scores indicate greater severity of symptoms.
次要结局
- Change in EORTC QLQ CIPN20 Motor Subscale From Baseline(Week 1, week 2, week 3, and week 4)
- Change in EORTC QLQ CIPN20 Autonomic Scale From Baseline(Week 1, week 2, week 3, and week 4)
- Incidence of Adverse Events (AEs)(Up to 14 days for each part of a sequence)
- Incidence of Grade 3 or Higher Adverse Events(Up to 28 days)