Effect of Hemp-CBD on Patients With CIPN
关键词
抽象
描述
CIPN is a common complication of many effective cytotoxic agents that can negatively impact patients' treatment course and quality of life. The incidence of CIPN in cancer patients receiving multidrug regimens is estimated at 38%, with frequencies approaching 100% with certain known neurotoxic drug classes. Taxanes (e.g., paclitaxel, docetaxel) and platinum-based agents (e.g., oxaliplatin, cisplatin, carboplatin) in particular, are two commonly used chemotherapy classes that are associated with a high incidence of CIPN. Symptoms of chemotherapy-induced peripheral neuropathy include distal extremity numbness, tingling and pain. Chronic, cumulative symptoms can severely impact quality of life and result in dose reductions and/or drug discontinuation in up to 30% of patients.
Consumers use cannabis products for various reasons including pain, stress, anxiety, and insomnia. The neuro-modulatory effects of phytocannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD) in particular, have been documented at both the molecular and clinical level. The endocannabinoid system consists of CB1 receptors and CB2 receptors that act as an inhibitory G-protein within the central and peripheral nervous system, respectively. Several animal models have demonstrated the role endocannabinoids play in neuropathic pain development by showing enhanced neuropathic pain with CB1 receptor deletion and reduced manifestations of neuropathic pain with CB2 receptor overexpression. The therapeutic properties of cannabis-based products have also been illustrated in several randomized double-blind trials that have shown significant pain relief versus placebo in the treatment of neuropathy related to diabetes, spinal cord injury, multiple sclerosis, and HIV associated polyneuropathy. Studies specifically looking at the role of CBD in chemotherapy-induced neurotoxicity have shown a neuroprotective effect of CBD in mouse models. Studies have demonstrated that a 14-day dosing regimen of CBD prevented the onset of paclitaxel-induced mechanical and thermal sensitivity.
These intriguing results suggest that cannabinoid agents could potentially reduce the severity and duration of CIPN in the clinical setting.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 04/22/2020 |
| 提交的预估入学人数: | 05/19/2020 |
| 首次发布: | 05/20/2020 |
| 上次提交的更新: | 06/15/2020 |
| 最近更新发布: | 06/16/2020 |
| 实际学习开始日期: | 05/26/2020 |
| 预计主要完成日期: | 09/30/2021 |
| 预计完成日期: | 03/31/2022 |
状况或疾病
干预/治疗
Drug: Hemp-based CBD
Other: Placebo Oral Tablet
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Hemp-based CBD | Drug: Hemp-based CBD 3x Daily dosing for 12 weeks |
| Placebo Comparator: Placebo Oral Tablet | Other: Placebo Oral Tablet 3x Daily dosing for 12 weeks |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Non-metastatic breast cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving taxane-based chemotherapy in pre-operative or post-operative setting. - Colorectal cancer patients with high risk stage II and stage III disease who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving oxaliplatin in the adjuvant setting. - Ovarian cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting . Exclusion Criteria: - Family history of genetic/familial neuropathy - Routine use of recreational or medicinal marijuana products (defined as > 4 times per month) or illicit drug use (positive urine drug screen including opioids, cocaine, amphetamines, PCP, LSD) - Known underlying liver disease (Child-Pugh B or C) or baseline elevation in ALT, AST or total bilirubin ≥1.5 x upper limit of normal - Patients taking certain medications will be excluded due to potential CBD-drug interaction. CBD may prevent appropriate drug metabolism increasing risk for toxicity. Co-administration of study product and the following medications will be contraindicated and may lead to participant exclusion: clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, warfarin, any opioids, warfarin, antiepileptic medications (including carbamazapine, phenytoin, valproic acid, but excepting of gabapentin, clonazepam or diazepam). - Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months - Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke or transient ischemic attack, or need for coronary stent placement within past six months. - Patients with uncontrolled psychiatric illness (who meet DSM-V criteria) or who are at increased risk for suicidality based on baseline Columbia-Suicide Severity Rating Scale. - Women who are pregnant or breastfeeding or who refuse to practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD) |
结果
主要结果指标
1. Change in pressure/touch sensation during intervention and at follow-up [Every two weeks for twelve weeks during intervention; Every month for three months follow-up]
2. Change in pain sensation during intervention and at follow-up [Every two weeks for twelve weeks during intervention; Every month for three months follow-up]
3. Change in vibration sensation during intervention and at follow-up [Every two weeks for twelve weeks during intervention; Every month for three months follow-up]
4. Change in quality of life [Every two weeks for twelve weeks during intervention; Every month for three months follow-up]
5. Change in CIPN symptom severity [Every two weeks for twelve weeks during intervention; Every month for three months follow-up]
6. Change in pain severity [Every two weeks for twelve weeks during intervention; Every month for three months follow-up]
7. Change in sleep quality [Every two weeks for twelve weeks during intervention; Every month for three months follow-up]
次要成果指标
1. Receptivity and accrual rate to clinical studies involving cannabis-based substances. [1 Day]
2. Adherence to CBD Products [Daily, 12 weeks]
3. Rate of side effects using medical-grade CBD concentrates [Daily, 12 weeks]
