Phase 1 Pilot Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of curcumin in combination with piperine
研究概览
简要总结
This pilot phase I trial studies the side effects and best dose of curcumin when given together with piperine (piperine extract [standardized]) in reducing inflammation for ureteral stent-induced symptoms in patients with cancer. Curcumin is a spice similar to turmeric and works by decreasing the chemical moderators that produce inflammation in the body. Piperine is pepper and works by increasing the amount of curcumin available in the body when taken with curcumin. Giving curcumin together with piperine may reduce inflammation and discomfort from a ureteric stent in older patients with cancer.
详细描述
PRIMARY OBJECTIVES:
I. To conduct a dose-escalation study with curcumin and piperine to derive a safe, optimal biological dose of this combination in cancer patients.
SECONDARY OBJECTIVES:
I. To describe the grade 2+ toxicities associated with curcumin and piperine. II. To evaluate quality of life associated with this combination by means of the Mayo Modified Urinary Stent Symptom Questionnaire (USSQ).
TERTIARY OBJECTIVES:
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
- •Ureteral stent in place at study registration
- •Patient reports pain, spasms, or urgency symptoms after stent placement, which are thought to be unrelated to other causes as per the patient or healthcare provider or both (documentation in the medical record is unnecessary)
- •Ability to complete English language questionnaires by themselves or with assistance
- •After the week-long study treatment, participants must be willing to return to the enrolling institution for a follow-up visit
- •Willingness to provide mandatory 24 hour urine collection samples for research purposes
- •Able to swallow supplements
- •Patient must have either a history of cancer or active cancer
- •Registration >= 7 days after placement of a new stent or >= 3 days after a stent exchange
- •Willingness to refrain from grapefruit juice for 7 days prior to and for 7 days during the study
排除标准
- •Receiving warfarin at registration
- •Active cholecystitis
- •Taking any of the following drugs at the time of study participation: epidermal growth factor receptor inhibitor, topoisomerase 1 inhibitor (camptothecin, irinotecan); buspirone, benzodiazepines, zolpidem, calcium channel blockers (such as felodipine, nifedipine, verapamil); digoxin or quinidine; codeine or fentanyl; phenytoin, propranolol, rifampin, or theophylline
- •History of alcohol abuse
研究组 & 干预措施
Supportive care (curcumin, piperine)
Patients receive curcumin PO BID or TID and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.
干预措施: Curcumin (Drug)
Supportive care (curcumin, piperine)
Patients receive curcumin PO BID or TID and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Supportive care (curcumin, piperine)
Patients receive curcumin PO BID or TID and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.
干预措施: Piperine Extract (Standardized) (Dietary Supplement)
Supportive care (curcumin, piperine)
Patients receive curcumin PO BID or TID and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Maximum tolerated dose (MTD) of curcumin in combination with piperine
时间窗: 7 days
The MTD of curcumin in combination with piperine is defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experiencing a DLT. DLT will be assessed using Common Terminology Criteria for Adverse Events version 4.0. Examined in an exploratory and hypothesis-generating fashion.
Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
时间窗: Up to 1 month post-treatment
Examined in an exploratory and hypothesis-generating fashion. The number and severity of all adverse events (overall, by dose-level, and by tumor type) will be tabulated and summarized in this patient population. The grade 2+ adverse events will also be described and summarized in a similar fashion.
Optimal biologically active dose for curcumin in combination with piperine extract (standardized)
时间窗: 7 days
Examined in an exploratory and hypothesis-generating fashion.
次要结局
- Change in quality of life (QOL) by means of the USSQ(Baseline to 7 days)