NCT05336266进行中（未招募）早期 1 期
IIT2021-16-Hendifar-KetoROCX: A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
Andrew Hendifar, MD1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.
研究概览
简要总结
The purpose of this study is to see if taking ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), is reasonable, safe and can stabilize or increase weight along with quality of life in pancreatic cancer patients.
详细描述
The main things that will happen in this study are: patients will be administered ketorolac for 5 days, blood draws, completion of questionnaires, monitoring physical activity and sleep by wearing a study-provided FitBit along with weight using a study-provided smart scale.
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
- •Diagnosis of advanced and refractory pancreatic ductal adenocarcinoma (PDAC) referred to Cedars-Sinai Medical Center (CSMC).
- •Cachexia defined as ≥5% weight loss in the presence of chronic illness, within any 6-month period prior to screening or as documented by the medical physician based on standard diagnosis of cachexia.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky performance status >50%.
- •Patient must have adequate renal function per below lab values:
- •Creatinine OR measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN.
- •Patient must have access to WiFi for the Smart Scale.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
- •Pregnancy, breastfeeding, or of childbearing potential and not willing to use adequate methods of contraception during the study.
- •Has any known allergies or hypersensitivity to the study drug or allergic reactions to surgical steel or elastomer/rubber.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Concurrent use of any other NSAIDs while on study.
- •Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding.
- •Have suspected or confirmed cerebrovascular bleeding, tendency to bleed or bruise easily, incomplete hemostasis (how you body stops bleeding), and at high risk of bleeding.
研究组 & 干预措施
Ketorolac (open label)
Experimental
Pancreatic patients receiving Ketorolac four times a day for up to five days
干预措施: Ketorolac Tromethamine (Drug)
结局指标
主要结局
Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.
时间窗: 6 days
Defined as 75% or more of patients taking the study medication as prescribed for 5 days in a 6-day period: compliance diary.
次要结局
- Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit(14 days)
- Mean change in peak heart rate from baseline(14 days)
- Mean change in sleep duration from baseline(14 days)
- Decrease in inflammatory biomarkers (CA-19 and CRP) from baseline(6 days)
- Mean change in calories consumed from baseline through the End-of-Treatment visit(6 days)
- To describe the adverse events associated with ketorolac when administered.(14 days)
- Mean change in daily activity (step taken) from baseline(14 days)
- Mean change in average heart rate from baseline(14 days)
- Mean change in sleep disturbances from baseline(14 days)
- Mean change in daily active minutes from baseline(14 days)
- Mean change in weight from baseline through the End-of-Study visit(14 days)
- Mean change in body fat from baseline through the End-of-Study visit(14 days)
- Evaluate change in physical function from baseline through the End-of Study visit(14 days)
研究者
Andrew Hendifar, MD
Assistant Professor, Medicine
Cedars-Sinai Medical Center
研究点 (1)
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