A Randomized Control Trial to Compare Doxycycline to Isotretinoin for the Treatment of Acneiform Eruptions in Cancer Patients on Tyrosine Kinase Inhibitors
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Quantitative improvement in acneiform eruptions in cancer patients on tyrosine kinase inhibitors as defined by a change in Leeds Revised Acne Grading Scale.
研究概览
简要总结
Tyrosine Kinase inhibitors (TKIs) have become standard of care in patients with EGFR mutations in non-small cell lung cancer and other EGFR-mutated cancers. However, TKIs are well-known to cause cutaneous adverse events, including acneiform eruptions. Moderate to severe acneiform eruptions are often associated with severe pruritus and pain. Current treatment recommendations rely on expert consensus. Moderate and severe reactions requiring systemic therapy, usually tetracycline antibiotics or isotretinoin. No randomized trial has compared the relative effectiveness of tetracyclines versus isotretinoin.
The objective of this unblinded, randomized trial is to compare tetracyclines to isotretinoin for treatment of moderate to severe acneiform eruptions in cancer patients on tyrosine kinase inhibitors. The primary aim of this clinical trial is to elucidate which systemic treatment is more effective in clearing acneiform eruptions caused by TKIs. The results of this study will add to the literature in this field and will aid in developing evidence based clinical guidelines.
详细描述
Background and Study Aims:
Tyrosine Kinase inhibitors (TKIs) have become standard of care in patients with EGFR mutations in non-small cell lung cancer and other EGFR-mutated cancers. However, TKIs are well-known to cause cutaneous adverse events, including acneiform eruptions. Moderate to severe acneiform eruptions are often associated with severe pruritus and pain. Current treatment recommendations rely on expert consensus. Moderate and severe reactions requiring systemic therapy, usually tetracycline antibiotics or isotretinoin. No randomized trial has compared the relative effectiveness of tetracyclines versus isotretinoin.
The objective of this unblinded, randomized trial is to compare tetracyclines to isotretinoin for treatment of moderate to severe acneiform eruptions in cancer patients on tyrosine kinase inhibitors. The primary aim of this clinical trial is to elucidate which systemic treatment is more effective in clearing acneiform eruptions caused by TKIs. The results of this study will add to the literature in this field and will aid in developing evidence based clinical guidelines. The study will be held at Jewish General Hospital, Division of Dermatology, G026, 3755 Cote Ste Catherine, Montreal (Quebec) H3T 1E2.
Who can participate? This study is open to adult patients (>18 years old) at the Jewish General Hospital who have a histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation. Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, a life expectancy of at least 3 months. Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding
What does the study involve?
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
- None
盲法说明
Unblinded
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
- •Participant must be ≥18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent
- •Participant has histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation.
- •Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale.
- •Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Participant has a life expectancy of at least 3 months.
- •Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding
排除标准
- •Absolute contraindications: pregnancy, breastfeeding, drug allergy
- •Relative contraindications:
- •moderate to severe hypercholesterolemia (total cholesterol >7.8 mmol/L)
- •hypertriglyceridemia (TG >2.55 mmol/L)
- •significant hepatic dysfunction (AST > 55IU/L, ALT > 94 IU/L)
- •suicidal ideation, pseudotumor cerebri
- •refractory nausea or vomiting
- •GI pathology that would prevent absorption of oral therapy.
研究组 & 干预措施
Doxycycline
Doxycycline 100mg po once daily x 6 months
干预措施: Doxycycline 100mg po once daily x 6 months (Drug)
Isotretinoin
Isotretinoin 40mg po once daily x 6 months
干预措施: Isotretinoin 40 mg po once daily x 6 months (Drug)
结局指标
主要结局
Quantitative improvement in acneiform eruptions in cancer patients on tyrosine kinase inhibitors as defined by a change in Leeds Revised Acne Grading Scale.
时间窗: 6 months
Change in Leeds revised acne grading scale score between the baseline visit and six months or end of treatment with tyrosine kinase inhibitor, whichever is sooner. Leeds revised acne score ranges from 1 to 28, with higher being worse. Mild defined as 3-8, moderate defined as 11-20 and severe defined as 21-28.
次要结局
- Quantitative change on patient's quality of life with treatment of the acneiform eruption as measured by the dermatology life quality index scale.(6 months)
- Response of malignancy to cancer therapy using RECIST v1.1 guidelines(6 months)
- Adverse events from the study medications as defined using the CTCAE version 5.0 guidelines(6 months)
研究者
Kevin Pehr
Senior Investigator/Chercheur Clinicien
Lady Davis Institute