A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment with respect to duloxetine of the effect of lorcaserin on the Pain Numerical Rating Scale.
研究概览
简要总结
A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
详细描述
To examine lorcaserin a selective R-HT2c receptor antagonist approved by FDA as weight loss drug- for its ability to improve proprioceptive movements in patients with advanced colorectal cancer who developed neurotoxicity during oxaliplatin-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Coded Bottles
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
- •Subject has a diagnosis of invasive colorectal cancer, locally advanced or advanced, requiring oxaliplatin-based chemotherapy for treatment.
- •Subject has agreed to receive treatment at Cancer Treatment Centers of America, Southeastern Regional Medical Center.
- •Subject is Male or Female
- •Subject is 18 years of age or older.
- •Subject is a patient who reports neurotoxicity symptom grade 2 or more according CTCAE criteria to his or her medical oncologist following one or more cycles of oxaliplatin-based chemotherapy treatment.
- •Subject is a patient who is capable and accepting of completing study questionnaires at each data collection point.
- •Subject has adequate English fluency for completion of data collection. The surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
- •Subject must have the ability to understand and the willingness to sign a written informed consent
- •Subject must be willing to comply with all study procedures and be available for the duration of the study.
排除标准
- •Subjects who have previously been exposed to neurotoxic agents including pyridoxine (>100 mg/day), colchicine, allopurinol, or phenytoin;
- •Subjects with pre-existing comorbidities, such as: diabetes, uremia, significant peripheral vascular disease, HIV, or progressive or degenerative neurologic disorders (e.g., multiple sclerosis, B12 deficiency); cardiovascular valve disease, history of cardiovascular event,
- •Subjects with a history of lumbosacral laminectomy or radiculopathy;
- •Subjects who have been prescribed and taken gabapentin, pregabalin, or duloxetine currently or within the last 1 months)
- •Subjects who have established or suspected family history of inherited neuropathy.
- •Subjects unable to swallow indicated medication
- •Subjects in general with a medical condition, laboratory finding, or physical exam finding that precludes participation
- •Subject weight of ≥350 lbs.
- •Subjects who currently use disallowed concomitant medications
- •Subjects with any form of cardiac implants
- •Subjects who report recent febrile illness that precludes or delays participation
- •Subjects with pregnancy or lactation
- •Subjects with known allergic reactions to components of the study product(s)
- •Subjects receiving treatment with another investigational drug or other intervention
- •Subjects with a history of or current tobacco or illegal substance use
- •Subjects exhibiting significant psychiatric or cognitive impairment (dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
研究组 & 干预措施
Intervention
Lorcaserin 10 mg bid
干预措施: Lorcaserin (Drug)
Control
Duloxetine 60 mg qd
干预措施: Duloxetine 60 mg qd (Drug)
结局指标
主要结局
Assessment with respect to duloxetine of the effect of lorcaserin on the Pain Numerical Rating Scale.
时间窗: 180 days
Duloxetine efficacy as Measured by Pain Score 0-10 Numerical Rating Scale. Subject will rate level of pain experienced from 0 (No Pain) to 10 (Worst Possible Pain) for each question on the Brief Pain Inventory Short Form. A rating of 5 would be Moderate Pain.
Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.
时间窗: 180 days
Subject quality of life will also be measured using the MD Anderson Symptom Inventory (MDASI) Questionnaire, with CTCA addendum. For each statement, the subject will answer from 0-10, with 0 being "Not Present" and 10 being "As Bad as You Can Imagine)
次要结局
未报告次要终点