The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory-Short Form (BPI)
研究概览
简要总结
Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing breast cancer treatment. Some patients may need to shorten their course of treatment, and do not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The goal of this study is to investigate the cannabinoids THC and CBD for TIPN.
详细描述
The investigators' goal is to study the efficacy of cannabinoids as a potential treatment for TIPN. Volunteers with a diagnosis of breast cancer and chemotherapy-induced peripheral neuropathy, secondary to treatment with paclitaxel or docetaxel, will be enrolled. This study involves the administration of cannabinoids in different strength capsules. The primary outcome measures include measures of pain and functional impairment (non-painful symptoms). The scales will include: 1) Brief Pain Inventory-Short Form (BPI) for pain severity ; and 2) BPI pain interference subscale for functional impairment. The study outcomes will also include secondary measures of perception, which will be performed in the laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.
- •Participants must have an ECOG score of 2 or better. Participants must have a score of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria Adverse Events (CTCAE).
- •Able to give informed consent and comply with all study procedures.
排除标准
- •Diagnosis of a major medical, neurological, or psychiatric disorder that would preclude study participation.
- •Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
- •Subjects taking warfarin.
- •Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.
研究组 & 干预措施
Cannabinoids (THC and CBD)
THC and CBD
干预措施: Cannabinoids (Drug)
Placebo Cannabinoids
placebo cannabinoids
干预措施: Cannabinoids (Drug)
结局指标
主要结局
Brief Pain Inventory-Short Form (BPI)
时间窗: value at the later time (8 weeks) point minus the value at the earlier time point (baseline)
This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10
次要结局
未报告次要终点
研究者
Diana Martinez
Psychiatrist II
New York State Psychiatric Institute