Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Vestermarksvej 9, 4000, Roskilde, Denmark.
Survivorship & Inequality in Cancer, Danish Cancer Society Research Center, 2100, Copenhagen, Denmark.
Support Care Cancer. 2022 Nov;30(11):9441-9451. doi: 10.1007/s00520-022-07312-y. Epub 2022 Aug 6.
To assess the safety, dosing, and preventive effects of cannabidiol (CBD) on chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving oxaliplatin- or paclitaxel-based chemotherapy.
Patients with cancer scheduled to undergo treatment with carboplatin and paclitaxel (Carbo-Tax) or capecitabine and oxaliplatin (CAPOX) received 150 mg CBD oil twice daily (300 mg/daily) for 8 days beginning 1 day before initiation of chemotherapy. Ten CIPN-specific patient-reported outcome (PRO) measures were captured at baseline and each day after the first cycle of chemotherapy for 8 days. Multi-frequency vibrometry (MF-V) was captured at baseline and day 4 ± 1 after initiation of chemotherapy. Controls were obtained from a similar patient cohort that did not receive CBD. Adverse events were captured using the CTCAE ver. 4.03.
From March to December 2021, 54 patients were recruited. CBD-treated patients were significantly older (p = 0.013/0.037, CAPOX/Carbo-Tax) compared to controls. Patients receiving CBD and CAPOX or Carbo-Tax showed significantly lower (better) change in Z-scores in high-frequency MF-V (125 and 250 Hz) compared to controls. This difference was most pronounced for patients receiving Carbo-Tax (- 1.76, CI-95 = [- 2.52; - 1.02] at 250 Hz). CAPOX patients treated with CBD had significantly lower peak baseline-adjusted difference in three PRO items on cold sensitivity to touch, discomfort swallowing cold liquids, and throat discomfort (- 2.08, - 2.06, and - 1.81, CI-95 = [- 3.89; - 0.12], NRS 0-10). No significant differences in PRO items were found for patients receiving Carbo-Tax. Possible side effects included stomach pain (grades 1-2) for patients receiving CAPOX.
CBD attenuated early symptoms of CIPN with no major safety concerns. Long-term follow-up is ongoing. Results should be confirmed in a larger, randomized study.
NCT 04,167,319 (U.S National Library of Medicine; ClinicalTrials.gov). Date of registration: November 18, 2019.
评估大麻二酚（CBD）在接受奥沙利铂或紫杉醇为基础的化疗的患者中预防化疗引起的外周神经病变（CIPN）的安全性、剂量和预防作用。
计划接受卡铂和紫杉醇（Carbo-Tax）或卡培他滨和奥沙利铂（CAPOX）治疗的癌症患者在化疗开始前 1 天开始，每日两次服用 150mg CBD 油（300mg/d），连续 8 天。在化疗第一周期的 8 天内，每天记录 10 项 CIPN 特定的患者报告结局（PRO）测量值。在化疗开始后第 4 天±1 天进行多频振动计（MF-V）检测。对照组来自未接受 CBD 的类似患者队列。使用 CTCAE ver.4.03 评估不良事件。
2021 年 3 月至 12 月期间，共招募了 54 名患者。与对照组相比，接受 CBD 治疗的患者年龄明显较大（p=0.013/0.037，CAPOX/Carbo-Tax）。与对照组相比，接受 CBD 联合 CAPOX 或 Carbo-Tax 的患者高频 MF-V（125 和 250Hz）的 Z 分数变化明显更低（更好）。对于接受 Carbo-Tax 的患者，这种差异最为明显（-1.76，95%CI-95=-2.52；-1.02，在 250Hz 时）。接受 CBD 治疗的 CAPOX 患者在三项与触摸冷敏感、吞咽冷液体不适和喉咙不适相关的 PRO 项目中，其基线调整后的峰值差异显著降低（-2.08、-2.06 和-1.81，95%CI-95=-3.89；-0.12，NRS 0-10）。接受 Carbo-Tax 的患者在 PRO 项目中没有发现显著差异。接受 CAPOX 的患者可能出现胃痛（1-2 级）。
CBD 减轻了 CIPN 的早期症状，无重大安全性问题。正在进行长期随访。结果需要在更大的随机研究中得到证实。
NCT 04,167,319（美国国立医学图书馆；ClinicalTrials.gov）。注册日期：2019 年 11 月 18 日。
