A Hair Loss Prevention Study for Patients With Advanced Pancreatic Cancer Utilizing Scalp Cooling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Hair Preservation
研究概览
简要总结
Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.
详细描述
Patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin will experience hair preservation with the use of the Paxman scalp cooling device, at the end of three, 3 week cycles of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Willing and able to provide written informed consent/assent for the trial
- •>18 years of age on day of signing informed consent
- •Diagnosis of pancreatic cancer and scheduled to receive treatment with a regimen containing nab-paclitaxel, gemcitabine and cisplatin
排除标准
- •Grade 1 alopecia
- •Existing history of scalp metastases or the presence of scalp metastases is suspected
- •No history of previous cancers within the past 5 years
- •Central Nervous System (CNS) malignancies (either primary or metastatic)
- •Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, post-traumatic cold dystrophy
- •Imminent bone marrow ablation chemotherapy
- •Imminent skull radiation
- •Previously received or scheduled to undergo skull irradiation
- •Severe liver or renal disease from any etiology as patient may not be able to metabolize or clear the metabolites of the chemotherapeutic agent
- •Skin cancers including melanoma, squamous cell carcinoma and Merkel cell carcinoma
- •Small cell carcinoma of the lung
- •Solid tumors that have a high likelihood for metastasis in transit
- •Squamous cell carcinoma of the lung
研究组 & 干预措施
Paxman Scalp Cooling Device
Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
干预措施: Paxman Scalp Cooling Device (Device)
结局指标
主要结局
Hair Preservation
时间窗: 28 to 84 days
Hair preservation was graded and defined based on severity of hair loss (alopecia) Grade 0 or 1 (lower grade) versus Grade 2 (higher grade) as defined by the CTCAE Version 5.0. Grade 0 to 1 is defined as Hair loss of \<50% of normal for that individual that is not obvious from a distance but only on close inspection; Grade 2 or higher is Hair loss of \>=50% normal for that individual that is readily apparent to others.
次要结局
- Patient Comfort(1 to 84 days)
- Chemotherapy-Induced Alopecia Distress(1 to 84 days)