A Phase II Trial of Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy.
研究概览
简要总结
This protocol describes a phase II trial investigating the efficacy of CBD in paclitaxel- and oxaliplatin-induced peripheral neuropathy. The trial uses multiple assessments such as validated PRO-questionnaires and multifrequency vibrometry.
详细描述
Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to omission or even discontinuation of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •≥ 18 years of age.
- •A diagnosis of cancer.
- •Fulfill criteria for starting chemotherapy.
- •Scheduled to undergo at least 6 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy.
- •If not postmenopausal (defined as no menses for 12 months without an alternative medical cause), women will have use effective anti-contraception (using definitions in the CTFG*-Recommendations related to contraception and pregnancy testing in clinical trials) and submit to a monthly pregnancy test (blood test).
排除标准
- •Unable to complete PRO-measurements.
- •Previously received taxanes or platinum-based chemotherapy.
- •If using any antiepileptic or antidepressant medicine (ATC: N03A or N06A). Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam (N05BA09) is not allowed due to major interaction with cannabidiol.
- •Use of cannabinoids. If in use, treatment must be stopped 4 days prior to inclusion.
- •Hypersensitivity reactions towards Ascorbylpalmitat or Triglycerides (medium-chain)
- •Baseline transaminase level must not be above 3 times the Upper Limit of Normal (ULN) at study beginning.
- •Women who are breastfeeding.
- •Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C
- •CTFG: The Heads of Medicines Agencies commissioned Clinical Trials Facilitation Group under the European Union's clinical trials directive 2001/20.
研究组 & 干预措施
Cannabidiol
Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment
干预措施: Cannabidiol 100 MG/ML (Drug)
结局指标
主要结局
Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy.
时间窗: up to 5 days
Difference in the North Central Cancer Treatment Group (NCCTG)- acute-CIPN Questionnaire from baseline compared to 3-5 days after initiation of chemotherapy course no. 1. The Questionnaire contains single items questions, answerable on a 0-10 numeric scale, 0 corresponds to no symptoms and 10 worst possible symptoms.
Difference in Vibrograms from baseline and during 1. course chemotherapy.
时间窗: up to 5 days
Difference in the Vibrograms from baseline compared to 3-5 days after initiation of chemotherapy course no. 1.
次要结局
- Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 6th course of chemotherapy or the last course of chemotherapy (if before course no. 6).(through study completion, an average of 1 year and 6 months)
- Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 4th course of chemotherapy or the last course of chemotherapy (if before course no. 4)(through study completion, an average of 1 year and 6 months)
- Difference in CIPN from baseline to after chemotherapy course no. 3(through study completion, an average of 1 year and 6 months)
- Difference in CIPN from baseline to 1. follow-up (OX)(through study completion, an average of 1 year and 9 months)
- Difference in CIPN from baseline to after chemotherapy course no. 6(through study completion, an average of 1 year and 6 months)
- Difference in CIPN from baseline to 1. follow-up (PAC)(through study completion, an average of 1 year and 9 months)
- Difference in the Vibrograms after chemotherapy course 1(through study completion, an average of 1 year and 6 months)
- Dose reductions(through study completion, an average of 1 year and 6 months)
- Dose delays(through study completion, an average of 1 year and 6 months)
- Difference in CIPN from baseline to after chemotherapy course no. 2(through study completion, an average of 1 year and 6 months)
- Difference in CIPN from baseline to after chemotherapy course no. 4(through study completion, an average of 1 year and 6 months)
- Difference in QoL from baseline to after chemotherapy course no. 3(through study completion, an average of 1 year and 6 months)
- Difference in QoL from baseline to after chemotherapy course no. 6.(through study completion, an average of 1 year and 6 months)
- Difference in QoL from baseline to after chemotherapy course no. 4(through study completion, an average of 1 year and 6 months)
- Difference in QoL from baseline to after chemotherapy course no. 2(through study completion, an average of 1 year and 6 months)
- Difference in the Vibrograms after chemotherapy course 2(through study completion, an average of 1 year and 6 months)
- Not completing planned courses of chemotherapy(through study completion, an average of 1 year and 6 months)