RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 6
- 主要终点
- Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score
研究概览
简要总结
This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.
详细描述
PRIMARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on pain related to paclitaxel-associated acute pain syndrome (P-APS). SECONDARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on paclitaxel-induced peripheral neuropathy. II. To obtain pilot data regarding the possible relative toxicities related to pregabalin therapy in this study situation. TERTIARY OBJECTIVES: I. To characterize neurological testing abnormalities that might occur with the P-APS, and to evaluate neurological testing abnormalities during the period of the longer-term chemotherapy-induced peripheral neuropathy (CIPN). II. To determine the PRO incidence and characteristics of, and change in, P-APS and paclitaxel induced more chronic CIPN over several cycles. These data will serve to confirm the results obtained in our previous natural history study N08C1. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pregabalin orally (PO) twice daily (BID), beginning on the first night of chemotherapy, for 12 weeks and then once daily (QD) for 1 week. ARM II: Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. After completion of study treatment, patients are followed up every 30 days for 6 months.
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
- •Age > or equal to 18 years
- •Ability to complete questionnaires by themselves or with assistance Paclitaxel at a dose of 80 mg/m^2 given, in the adjuvant setting, every week for a planned course of 12 weeks without any other concurrent therapy
- •Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors).
- •Life expectancy > 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (per clinician discretion)
排除标准
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
- •Previous diagnosis of diabetic or other peripheral neuropathy
- •Current, planned or previous use, within last 6 months, of gabapentin or pregabalin
- •History of allergic or other adverse reactions to gabapentin or pregabalin
- •Significant renal insufficiency with a history of a creatinine clearance (CrCL) < 30ml/min
- •Prior exposure to neurotoxic chemotherapy
- •Seizure history
- •Diagnosis of fibromyalgia
- •Previous exposure to paclitaxel
研究组 & 干预措施
Arm I (pain therapy)
Patients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
干预措施: pregabalin (Drug)
Arm I (pain therapy)
Patients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
干预措施: questionnaire administration (Other)
Arm II (placebo)
Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
干预措施: placebo (Drug)
Arm II (placebo)
Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score
时间窗: From treatment initiation to 6 days following treatment initiation; up to 7 days
Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1).
时间窗: From treatment initiation to 6 days following treatment initiation; up to 7 days
Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
次要结局
- Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment.(From treatment initiation to 6 days following treatment initiation; up to 7 days)
- Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment(Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment)
- The Percentage of Patients Who Use Non-prescription Pain Medications(From treatment initiation to 6 months.)
- The Percentage of Patients Taking Opioid Medications(From treatment initiation to 6 months.)
- The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel(From treatment initiation to 6 days following treatment initiation; up to 7 days)
- The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V)(From treatment initiation to 6 days following treatment initiation; up to 7 days)
- The Percentage of Patients Who Report, at Week's End, Using Non-prescription Pain Medications(From treatment initiation to 6 days following treatment initiation; up to 7 days)
- The Percentage of Patients Who Report, at Week's End, Using Opioids(From treatment initiation to 6 days following treatment initiation; up to 7 days)
- Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales(From treatment initiation to 6 months.)