A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort
研究概览
简要总结
This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab
详细描述
PRIMARY OBJECTIVES:
I. Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.
SECONDARY OBJECTIVES:
I. Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.
II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.
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
- Double (Participant, Investigator)
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
- •Age 18 years or older.
- •Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity.
- •Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face.
- •Ability to complete questionnaire(s) by themselves or with assistance.
- •Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only.
- •Willing to have photographs taken to assess rash.
排除标准
- •Any active facial and/or chest rash, including adult acne, at the time of randomization.
- •Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest.
- •Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks.
- •Any type of ongoing therapy for rash.
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
- •Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.
研究组 & 干预措施
Arm I (lotion)
Patients apply menadione topical lotion BID for 28 days.
干预措施: menadione topical lotion (Drug)
Arm I (lotion)
Patients apply menadione topical lotion BID for 28 days.
干预措施: questionnaire administration (Other)
Arm I (lotion)
Patients apply menadione topical lotion BID for 28 days.
干预措施: management of therapy complications (Procedure)
Arm II (placebo)
Patients apply topical placebo lotion BID for 28 days.
干预措施: placebo (Other)
Arm II (placebo)
Patients apply topical placebo lotion BID for 28 days.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort
时间窗: From Baseline to Week 4
Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.
次要结局
- Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)(Baseline, Week 4)
- Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)(Baseline, 4 weeks)
- The Number of Patients Experiencing Worst Toxicity(Up to 8 weeks)