NCT04180579进行中（未招募）不适用
Safety and Tolerability of Lower Scalp Cooling Temperatures to Prevent Doxorubicin Plus Cyclophosphamide and Paclitaxel-induced Alopecia in Breast Cancer Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Safety as assessed by CTCAE
研究概览
简要总结
This study is being done to determine if using the Paxman Scalp Cooling System at temperatures lower than the current standard is a safe and tolerable approach to prevent hair loss in breast cancer patients receiving 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •New diagnosis of breast cancer stage I-IV
- •Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
- •Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline plus cyclophosphamide followed by taxane based chemotherapy regimen:
- •Concurrent trastuzumab at standard doses is allowed
- •Concurrent pertuzumab at standard doses is allowed
- •Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated
- •For women of childbearing potential, a negative pregnancy test is needed within 7 days prior to study intervention, or whenever collected as per standard of care. For women who undergo fertility preservation or ovarian stimulation, a negative pregnancy test is not needed and eligibility due to positive pregnancy test will be determined by investigator discretion.
排除标准
- •Any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
- •Baseline alopecia (defined CTCAE v5.0 grade > 1)
- •Subjects who are scheduled for bone marrow ablation chemotherapy
- •Male gender
- •Age >/= 75 years
- •Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the Principal Investigator.
- •Subjects who have had prior chemotherapy
- •Subjects who have had >/=1 previous chemotherapy exposure resulting in alopecia
- •An existing history of scalp metastases or suspected presence of scalp metastasis
- •Subjects with cold sensitivity, cryoglobulinemia, cryofibrinogenemia, or cold migraine pot-traumatic cold dystrophy
- •Previously received, or scheduled to undergo skull irradiation
研究组 & 干预措施
Participants with Breast Cancer
Experimental
Any adult woman with a new diagnosis of breast cancer, Stage I-III
干预措施: PAXMAN Scalp Cooler (Device)
结局指标
主要结局
Safety as assessed by CTCAE
时间窗: Up to 44 weeks from the start of treatment
Safety will be determined by toxicity assessment according to CTCAE
次要结局
未报告次要终点
研究者
研究点 (1)
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