The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This will be an open-label, single group supportive care pilot study in which patients are given cannabinoid gummies in the perioperative setting to alleviate RC/UD symptoms and improve quality of life. The primary objective will be to evaluate the safety and tolerability of a cannabigerol supplement used perioperatively (from 14 days prior to surgery to 30 days following surgery) by patients undergoing radical cystectomy with urinary diversion (RC/UD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 or older
- •Non-metastatic bladder cancer scheduled to undergo radical cystectomy and urinary diversion
- •Patient is able to understand consent and is willing and able to provide written informed consent
- •Patient makes their own medical decisions
- •Lives in state of California
- •Patient is able and willing to refrain from using any non-study cannabis during the screening and treatment phases of the study
- •Females of childbearing potential to utilize an acceptable birth control method while consuming the gelatin-based chewable medication
- •Be able to read and understand the study questionnaires
- •Patient agrees to not to operate heavy machinery or engage in activities that require mental alertness while taking the gelatin-based chewable cannabigerol medication, as these substances may cause drowsiness.
排除标准
- •History of substance abuse
- •History of psychosis or schizophrenia
- •CBD or Cannabigerol usage in the last 30 days
- •THC usage in the last 30 days
- •Pregnant or breastfeeding individuals
- •Patients who have had heart attack or acute coronary syndrome in the 90 days prior to surgery
研究组 & 干预措施
Cannabigerol Gummies
Participants will receive cannabigerol gummies (oral, gelatin-based chewable formulation), 25 milligrams per gummy. Dosing will begin approximately 2 weeks prior to cystectomy with urinary diversion at 12.5 milligrams (one-half gummy) three times daily after meals. Based on tolerability, the dose may be increased to 25 milligrams (one gummy) three times daily or reduced to 6.25 milligrams (one-quarter gummy) 1 to 3 times daily. Treatment will continue through the perioperative period and up to 30 days postoperatively.
干预措施: Cannabigerol (Drug)