NCT04592731已完成不适用
A Clinical Trial to Evaluate the Efficacy and Safety of Acetylated Natural Nucleotides in Treating Hand-foot Syndrome (HFS)
Nan xu1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年11月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1
研究概览
简要总结
The clinical trial is planned to investigate the efficacy and safety of acetylated natural nucleotides in treating anti-cancer medications induced hand-foot syndrome (HFS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or older.
- •Pathologically confirmed cancer receiving capecitabine-based anti-cancer therapy (capecitabine with or without other anti-cancer drugs).
- •With HFS determined by "CTCAE v5.0 - PPE" as grade 2 or above.
- •Able to use topical medications and complete questionnaires reliably with or without assistance.
- •ECOG performance score < 2.
排除标准
- •Has HFS due to other medications and does not recover within 4 weeks prior to baseline.
- •Other skin disorders that will affect efficacy evaluation on the hands and feet, including but not limited to: tinea of feet and hands, hand/foot eczema, palmoplantar pustulosis, palmoplantar keratosis, acrodermatitis continua etc.
- •Uncontrolled intercurrent illness as determined by the investigator including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, uncontrolled hypotension or hypertension, cardiac arrhythmia, or psychiatric illness and social situations that would limit compliance with study requirements.
- •Significantly abnormal lab test:
- •Inadequate hematologic function as indicated by:
- •Absolute neutrophil counts (ANC) < 1,500 /mm^3
- •Hemoglobin (Hgb) < 8.5 g/dL
- •Platelet count < 75,000 /mm^3
- •PT or PTT > 1.5 x ULN (if patients on anticoagulants: PT INR > 3.5 x ULN)
- •Inadequate renal and liver function as indicated by:
- •Albumin < 2.8 g/dL
- •Total bilirubin > 1.5 x ULN (or > 2.5 x ULN for patients with Gilbert's syndrome)
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase > 2 x ULN
- •Creatinine > 2 x ULN
- •Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
研究组 & 干预措施
Gel containing Acetylated Natural Nucleotides
Experimental
干预措施: Gel containing Acetylated Natural Nucleotides (Drug)
Vehicle Gel
Placebo Comparator
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1
时间窗: 6 weeks
The proportion of patients who achieve "NCI CTCAE v5.0 - PPE" grade 0 or 1 at week 6 from grade 2 or above at baseline
次要结局
- Safety of study drug(6 weeks)
- Proportion of patients who achieve at least one grade improvement in HFS severity(6 weeks)
- Change from baseline in patient reported pain using Visual Analog Scale (VAS)(6 weeks)
- Change from baseline in Hand-Foot Skin Reaction and Quality of Life (HF-QoL) Questionnaire total score(6 weeks)
- The proportion of patients whose anti-cancer medications are impacted due to HFS(6 weeks)
研究者
Nan xu
Department Head in Dermatology
Shanghai East Hospital
研究点 (1)
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