A Pilot Randomized, Placebo-controlled, Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20
研究概览
简要总结
You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)
详细描述
PRIMARY OBJECTIVES:
I. To explore whether venlafaxine can prevent or ameliorate chronic, cumulative neurotoxicity associated with oxaliplatin in cancer patients receiving oxaliplatin, fluorouracil, leucovorin calcium (FOLFOX).
SECONDARY OBJECTIVES:
I. To explore whether venlafaxine can ameliorate acute neuropathy associated with oxaliplatin.
TERTIARY OBJECTIVES:
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
- •Scheduled to receive FOLFOX chemotherapy with individual oxaliplatin doses of 85 mg/m^2 per cycle given in 2 week cycles (e.g. modified [m] FOLFOX6 or FOLFOX4) Adequate complete blood count (CBC) and creatinine values (per attending physician) obtained =< 28 days prior to registration Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2 Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential Ability to complete questionnaire(s) by themselves or with assistance Life expectancy >= 4 months Strong inhibitors of CYP3A4: > 5-fold increase in the plasma area under the curve (AUC) values or more than 80 % decrease in clearance
- •Indinavir (Crixivan®)
- •Nelfinavir (Viracept®)
- •Atazanavir (Reyataz®)
- •Ritonavir (Norvir®)
- •Clarithromycin (Biaxin®, Biaxin XL®)
- •Itraconazole (Sporanox®)
- •Ketoconazole (Nizoral®)
- •Nefazodone (Serzone®)
- •Saquinavir (Fortovase®, Invirase®)
- •Telithromycin (Ketek®) Inducers of CYP3A4
- •Efavirenz (Sustiva®)
- •Nevirapine (Viramune®)
- •Carbamazepine (Carbatrol®, Epitol®, Equetro™, Tegretol®, Tegretol-XR®)
- •Modafinil (Provigil®)
- •Phenobarbital (Luminal®)
- •Phenytoin (Dilantin®, Phenytek®)
- •Pioglitazone (Actos®)
- •Rifabutin (Mycobutin®)
- •Rifampin (Rifadin®)
- •St. John's wort
排除标准
- •Any of the following:
- •Pregnant women
- •Nursing women History of an allergic reaction to, or intolerance of, venlafaxine Treatment =< 7 days with other antidepressants, anticonvulsants, monoamine oxidase (MAO) inhibitors, or other neuropathic pain medication agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, or amifostine; in addition, they may not be taking other agents for the treatment of neuropathy, nor other known moderate or strong CYP 2D6 (which consist of Cinacalcet [Sensipar™], quinidine, and Terbinafine [Lamisil®, Lamisil AT®]), nor the strong inducer of CYP 2D6 terbinafine (Lamisil®, Lamisil AT®), nor the following drugs that substantially effect CYP 3A4 Moderate inhibitors of CYP3A4: > 2-fold increase in the plasma AUC values or 50-80% decrease in clearance
- •Aprepitant (Emend®)
- •Erythromycin (Erythrocin®, E.E.S. ®, Ery-Tab®, Eryc®, EryPed®, PCE®
- •Fluconazole (Diflucan®)
- •Grapefruit juice
- •Verapamil (Calan®, Calan SR®, Covera-HS®, Isoptin SR®, Verelan®, Verelan PM®)
- •Diltiazem (Cardizem®, Cardizem CD®, Cardizem LA®, Cardizem SR®, Cartia XT™, Dilacor XR®, Diltia XT®, Taztia XT™, Tiazac®) Other medical conditions which, in the opinion of the treating physician/allied health professional, would make this protocol unreasonably hazardous for the patient Prior neurotoxic chemotherapy Concurrent radiotherapy Current (within the last month) pre-existing peripheral neuropathy of any grade Uncontrolled hypertension (defined as 3 consecutive readings over the past year of over 160 systolic, and over 100 diastolic)
研究组 & 干预措施
Arm I (management of therapy complications)
Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.
干预措施: venlafaxine (Drug)
Arm I (management of therapy complications)
Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.
干预措施: questionnaire administration (Other)
Arm I (management of therapy complications)
Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.
干预措施: quality-of-life assessment (Other)
Arm II (placebo)
Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
干预措施: placebo (Drug)
Arm II (placebo)
Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
干预措施: questionnaire administration (Other)
Arm II (placebo)
Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
干预措施: quality-of-life assessment (Other)
结局指标
主要结局
Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20
时间窗: Up to 2 weeks
The EORTC QLQ-CIPN20 sensory neuropathy score will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation.
次要结局
- Cycle 1 Acute Neuropathy as Measured by EORTC QLQ CIPN20 Motor Subscale (Items 37, 38, 41-45 and 49), and Autonomic Scale (Items 46, 47, 50)(Up to 2 weeks)