Treatment of Established Chemotherapy-Induced Neuropathy With N-Palmitoylethanolamide, a Cannabimimetic Nutraceutical: A Randomized Double-Blind Phase II Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score
研究概览
简要总结
This phase II trial tests whether PEA works to relieve the symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer. Chemotherapy-induced peripheral neuropathy refers to a nerve problem that causes pain, numbness, tingling, or muscle weakness in different parts of the body, and is caused by chemotherapy. PEA may be useful against bothersome nerve symptoms.
详细描述
PRIMARY OBJECTIVE:
I. To look for evidence of the efficacy of PEA (N-palmitoylethanolamide) at two different doses relative to placebo responses, as a treatment for chemotherapy-induced neuropathy (CIPN).
SECONDARY OBJECTIVES:
I. To assess the safety of PEA at the two study doses. II. To evaluate changes in patient-reported quality of life from baseline to the end of 8 weeks.
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- •NOTE: Patients with a history of metastatic cancer or an ECOG performance status of 2 must have laboratory (lab) work completed =< 28 days prior to registration
- •Pain, numbness, tingling or other symptoms of CIPN of >= 3 months (90 days) duration for which the patient is seeking an intervention
- •Neurotoxic chemotherapy must have been completed >= 3 months (90 days) prior to registration and there must be no further planned neurotoxic -chemotherapy for > 2 months after registration Note: The study is limited to those with taxane- and/or platinum-based neuropathy
- •Patient must note tingling, numbness or pain symptoms of at least a four out of ten =< 7 days prior to registration.
- •Note: On a 0-10 scale where zero was 'no problem' and ten being 'as bad a problem that could be imagined': how much of a problem has numbness, tingling, and/or pain in your fingers and/or toes been in the past week?
- •Patient must be able to speak, read and comprehend English
- •For women of childbearing potential only, a negative urine or serum pregnancy test done =< 14 days prior to registration is required
- •A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- •NOTE: If the urine test cannot be confirmed as negative, a serum pregnancy test will be required
- •Life expectancy >= 6 months
- •Platelet count > 100,000/mm^3
- •NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
- •Absolute neutrophil count (ANC) >= 1,000/mm^3
- •NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
- •Hemoglobin > 11 g/dL
- •NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
- •Serum transaminase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) =< 1.2 x upper limit of normal (ULN)
- •NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have these labs completed =< 28 days prior to registration
- •Alkaline phosphatase =< 1.2 x ULN
- •NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
- •Serum creatinine =< 1.2 x ULN
- •NOTE: Patients with a history of metastatic cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
- •Able to swallow oral medication
- •Provide written informed consent =< 28 days prior to registration
排除标准
- •Currently receiving neurotoxic chemotherapy for a second cancer or recurrence of the primary cancer
- •Impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)
- •Evidence of residual cancer, per routine clinical practice-based parameters
- •Comorbid conditions:
- •Previous diagnosis of diabetic or another non chemotherapy induced peripheral neuropathy
- •Previous history of peripheral neuropathy prior to receiving neurotoxic chemotherapy
- •Neuropathy from human immunodeficiency virus (HIV) infection. Note: Patients with HIV infections are eligible as long as they do not have a neuropathy from their viral illness
- •Concurrent use of a cannabis product (tetrahydrocannabinol [THC] and/or cannabidiol [CBD]). Patients should have discontinued these products >= 4 weeks prior to registration
- •Current or previous use of PEA
- •Currently receiving or planning to start any of the following agents: opioids, duloxetine, gabapentin or pregabalin. Patients are eligible if they discontinue these medications >= 1 week prior to registration
- •Any of the following because the 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
研究组 & 干预措施
BID placebo
Patients receive placebo PO BID for 8 weeks.
干预措施: Placebo Administration (Drug)
BID placebo
Patients receive placebo PO BID for 8 weeks.
干预措施: Quality-of-Life Assessment (Other)
Higher-dose PEA
Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.
干预措施: Palmidrol (Drug)
Higher-dose PEA
Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Lower-dose PEA
Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.
干预措施: Palmidrol (Drug)
Lower-dose PEA
Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
QD placebo
Patients receive placebo PO QD for 8 weeks.
干预措施: Placebo Administration (Drug)
QD placebo
Patients receive placebo PO QD for 8 weeks.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score
时间窗: 8 weeks
Will be scored and summarized at each time point for each patient. The change from baseline to 8 weeks will then be calculated for each patient. The mean, standard deviation, and median (range) of the change will be calculated for each PEA arm and the combined placebo arm. The difference in change scores between each PEA arm and the combined placebo will be estimated along with a 95% confidence interval. For the primary analysis, the CIPN20 analysis dataset will include all eligible patients who are randomized, initiated treatment, and completed the baseline questionnaire. For patients who go off protocol treatment before 8 weeks, the score at their final observation will be used to calculate the change. The CIPN20 includes 20 items, each asking a participant to rate their experience with certain symptoms from 1 to 4, with 1 being no difficulty with the symptom and 4 being the most difficulty with the symptom. Answers are then summed to give a total score from 20 to 80.
次要结局
- Number of Participants Experiencing Grade 3+ Adverse Events(8 weeks)
- Mean Change of Quality of Life(8 weeks)