Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Severity of ITCH
研究概览
简要总结
Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.
详细描述
Investigators enroll patients affected by solid tumors which present itch refractory to standard treatment ("refractory group") and patients who did not receive any treatment for pruritus ("naïve group"). The intensity of itch will be evaluated with Visual Analogue Scale (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) will be administered after at least 1 week of standard systemic treatment. In the naïve group, Aprepitant will be administered after the first onset of severe pruritus. The primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive and refractory group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed diagnosis of solid tumor
- •treatment with anti-EGFR antibodies or TKIs
- •first onset of severe pruritus during treatment (≥7 on Visual Analogue Scale (VAS) score)
排除标准
- •oral treatment with antimycotics during 4 weeks preceding enrolment
- •topical treatment during the previous 2 weeks
- •concomitant,chronic renal or hepatic insufficiency , skin infection or dermatitis.
研究组 & 干预措施
Aprepitant
Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus
干预措施: Aprepitant (Drug)
Aprepitant after anti-itch standard therapy
Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week
干预措施: Aprepitant (Drug)
Aprepitant after anti-itch standard therapy
Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week
干预措施: Prednisone (Drug)
Aprepitant after anti-itch standard therapy
Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week
干预措施: Fexofenadine (Drug)
结局指标
主要结局
Severity of ITCH
时间窗: once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy
Patients is asked to grade the intensity of their itch on the VAS, with the strongest possible itch marked at the right end of the line (10) and no itch marked at the left end (0). The VAS score is registered in a diary supplied 7 days before starting the study and every week throughout the study period. Pruritus intensity is evaluated by VAS score once before Aprepitant administration, once 7 days after the first dose of Aprepitant and once a week until the end of biological therapy or the pruritus recurrence. Response (evaluated one week after the first Aprepitant dose) is defined as \> 50% reduction of pruritus intensity compared to the baseline value.
次要结局
未报告次要终点
研究者
Daniele Santini
MD, PhD
Campus Bio-Medico University