Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Measure the improvement in balance for patients with chronic CIPN
研究概览
简要总结
This phase I trial studies how well lorcaserin works in treating chemotherapy-induced peripheral neuropathy in patients with stage I-IV gastrointestinal or breast cancer. Chemotherapy-induced peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. This condition can occur in patients who have received taxane chemotherapy drugs, or the chemotherapy drug oxaliplatin. Lorcaserin may improve chemotherapy-induced peripheral neuropathy by reducing pain, preventing or relieving joint symptoms, and improving balance.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate preliminary efficacy of lorcaserin to improve balance decrements in patients with chronic chemotherapy-induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
I. To evaluate patient reported outcomes (PROs) after a one time dose of lorcaserin in patients with chronic CIPN.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient with known diagnosis of gastrointestinal (GI) cancer or breast cancer stages I-IV
- •Prior exposure to paclitaxel or oxaliplatin within last 24 months
- •Have symptomatic CIPN confirmed by self-report, as demonstrated by PRO measure, CIPN-20
- •If a female subject is with child bearing potential, she must have a negative pregnancy test at screening
- •Female subjects of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after completion of study treatment administration. Adequate contraception includes methods such as oral contraceptives, double barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse
- •Be willing and able to understand and sign the written informed consent document
排除标准
- •Is beyond 24 months out from completion of oxaliplatin or paclitaxel
- •Is asymptomatic for CIPN
- •Is currently pregnant or breast feeding as there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lorcaserin
- •Has any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient
研究组 & 干预措施
Treatment (lorcaserin)
Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.
干预措施: Lorcaserin (Drug)
Treatment (lorcaserin)
Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.
干预措施: Lorcaserin Hydrochloride (Drug)
Treatment (lorcaserin)
Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Measure the improvement in balance for patients with chronic CIPN
时间窗: Up to 4 weeks
Will be evaluated using a measure of postural control: root-mean-squared amplitude of center of pressure (COP) excursion for the medial-lateral axis of the body .
次要结局
- Improvement in patient-reported chemotherapy-induced peripheral neuropathy symptoms(Baseline up to 4 weeks)
研究者
Maryam Lustberg
Principal Investigator
Ohio State University Comprehensive Cancer Center