A Study to Investigate DigniCap Scalp Cooling on Black Patients for Prevention of Chemotherapy-induced Alopecia.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Success in hair preservation after at least four cycles of chemotherapy
研究概览
简要总结
The goal of this research study is to determine if the DigniCap Scalp Cooling System can help prevent chemotherapy-induced hair loss in Black patients.
详细描述
The purpose of this study is to assess whether the DigniCap Scalp Cooling System can help prevent chemotherapy-induced hair loss in Black patients undergoing treatment for breast cancer. The primary objective of this study is to provide a preliminary assessment of the efficacy of the DigniCap Scalp Cooling in Black patients as prevention for chemotherapy induced alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with early stage breast cancer (stage I-III)
- •Self-identify as Black
- •Planned therapy with taxane and/or anthracycline-based chemotherapy (at least 4 cycles must be planned)
- •≥ 21 years of age
- •Able to give informed consent
排除标准
- •Female pattern hair loss or hair loss disorder
- •Scalp folliculitis
- •Scalp psoriasis Scalp seborrheic dermatitis
- •Inflammatory scalp conditions such as lichen planopillaris or alopecia areata
- •Subjects wearing wigs or subjects who shave their hair prior to chemotherapy
- •Unable to provide consent or make allotted clinical visits
- •Subjects with cold agglutinin disease or cold urticaria
- •Unwilling to remove hair extensions during treatment phase which can interfere with study assessments
- •History or whole brain irradiation
- •History of prior systemic chemotherapy
结局指标
主要结局
Success in hair preservation after at least four cycles of chemotherapy
时间窗: From enrollment to the end of study (2 years)
Success is defined as CTCAE v5.0 alopecia grade 0 (no hair loss) or grade 1 (\<50% hair loss not requiring a wig). Failure is defined as CTCAE v5.0 grade 2 (≥50% hair loss, requiring use of a wig) or higher.
Success in hair preservation after at least four cycles of chemotherapy
时间窗: From enrollment to the end of study (2 years)
Success is defined as CTCAE v5.0 alopecia grade 0 (no hair loss) or grade 1 (\<50% hair loss not requiring a wig). Failure is defined as CTCAE v5.0 grade 2 (≥50% hair loss, requiring use of a wig) or higher.
次要结局
- To estimate participant reported comfort of using Digniticap(From enrollment to the end of study (2 years))
- Evaluate quality of life (QOL) during study treatment phase- HADS(From enrollment to the end of study (2 years))
- Evaluate quality of life (QOL) during study treatment phase- BIS(From enrollment to the end of study (2 years))
- To estimate participant reported comfort of using Digniticap(From enrollment to the end of study (2 years))
- Evaluate quality of life (QOL) during study treatment phase- HADS(From enrollment to the end of study (2 years))
- Evaluate quality of life (QOL) during study treatment phase- BIS(From enrollment to the end of study (2 years))
研究者
Pavani Chalasani
Professor of Medicine; Director, Division of Hematology Oncology
George Washington University