A Pilot Randomized, Placebo-Controlled Study to Test Auranofin (Ridaura®) to Control the Paclitaxel-Induced Pain Syndrome (PIAPS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
研究概览
简要总结
This randomized pilot clinical trial studies whether auranofin will relieve pain following paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being studied to see if it will decrease pain following paclitaxel.
详细描述
PRIMARY OBJECTIVES:
I. Determine whether one dose of auranofin given the day following administration of paclitaxel decreases pain as assessed by daily completion of the Modified Brief Pain Inventory scale for seven days.
SECONDARY OBJECTIVES:
I. Assess whether auranofin is well tolerated in this setting.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Absolute neutrophil count (ANC) >= 1500/mm^3
- •Platelet count (PLT) >= 100,000/mm^3
- •Creatinine =< 2 x upper limit of normal (ULN)
- •Either serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN
- •Total/direct bilirubin =< 1.5 x ULN
- •Alkaline phosphatase =< 1.5 x ULN
- •Hemoglobin >= 9 mg/dL
- •Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only
- •Previously experienced paclitaxel induced pain during a current or past paclitaxel treatment that the treating healthcare provider thinks is consistent with the paclitaxel-induced acute pain syndrome; note: formal documentation of prior pain is not required
- •Scheduled to receive paclitaxel at a dose >= 70 mg/m^2 =< 14 days from randomization
- •Ability to complete the questionnaires or to do so with assistance
排除标准
- •Pregnant women
- •Nursing women
- •Any woman of childbearing potential or male partner of a woman of childbearing potential unwilling to employ acceptable contraception throughout the study and for at least 30 days after the last dose of the study drug
- •History of gold-induced disorders, including but not limited to, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasias or other severe hematologic disorders; history of severe allergic or anaphylactic reactions or hypersensitivity to auranofin or other gold compounds
- •Currently receiving Dilantin (phenytoin) or auranofin or another gold-containing compound
- •Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofin
- •Currently receiving immune-modulating therapies
研究组 & 干预措施
Arm I (auranofin)
Patients receive auranofin PO on day 2.
干预措施: auranofin (Drug)
Arm I (auranofin)
Patients receive auranofin PO on day 2.
干预措施: questionnaire administration (Other)
Arm II (placebo)
Patients receive placebo PO on day 2.
干预措施: placebo (Other)
Arm II (placebo)
Patients receive placebo PO on day 2.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
时间窗: Up to 28 days
The primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms.
Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8
时间窗: Up to 8 days
Area under the curve (AUC) Summary of Worst Pain in the last 24 hours from days 2 to 8. On a scale of 0-100, with 100=Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.
次要结局
- Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8(Up to 28 days)
- Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4(Up to 28 days)
- Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain(Up to 5 days)
- Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5(Up to 5 days)
- Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8(Up to 8 days)
- Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.(Up to 6 days)
- Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.(Up to 5 days)