Measuring the Efficacy of Paxman Scalp Cooling to Prevent Chemotherapy Induced Alopecia (CIA) in Black Patients With Stage I-III Breast or Gynecological Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Patient reported rate of alopecia rate of alopecia
研究概览
简要总结
This study will measure the efficacy of scalp cooling with the Paxman Scalp Cooling (PSC) device in a diverse patient population with success measured as prevention of more than 50% hair loss during chemotherapy. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness. This study will examine the success rate of scalp cooling in black patients receiving chemotherapy for breast or gynecological cancer.
详细描述
The primary objective is to measure the efficacy of the PSC device in preventing CIA in this diverse patient population with success measured as prevention of >grade 2 alopecia by self-report using the modified Dean scale or the VAS scale in >50% of participants using the intervention. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness.
The study aims include delivery of scalp cooling at each chemotherapy cycle with measurements of CIA at assigned intervals using patient self-report measured by the modified Dean scale and the Visual Analog Scale (VAS) outlined below.
The secondary aims are provider assessments of alopecia as measured by the NCI grading scale of alopecia, adverse effects of scalp cooling procedures such as headaches, dizziness, and pain, reasons for refusal or drop-out of study intervention.
Psychosocial and quality-of- life (QOL) effects of CIA in study participants will be measured using patient reported outcomes. The EORTC QLQ-B45 and Chemotherapy-Induced-Alopecia-Distress Scale (CADS) will be administered at designated time intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I-III breast cancer patients
- •Stage I-III endometrial cancer patients
- •Stage I-III ovarian cancer patients
- •Self-identified as black: African, African-American, or Caribbean black are included . Patients of mixed race who identify as black are also included.
- •Planned for >4 cycles of chemotherapy in the neoadjuvant or adjuvant setting with curative intent
- •At least one chemotherapy agent being a taxane.
- •Ability to read and answer questions in English
- •Ability to sign informed consent for themselves.
- •Able to fit into one of available cap sizes
排除标准
- •Metastatic cancer patients
- •Patients who do not self-identify as black (see definition above)
- •History of cryoglobulinemia or cold agglutin disease
- •Prior chemotherapy
- •Non-taxane chemotherapy regimens (anthracycline based chemotherapy regimens are eligible for breast cancer patients)
- •Baseline alopecia
- •Concurrent medications to prevent hair loss
- •Cold urticaria and cold- induced anaphylaxis
- •Unable to fit into an available cap size
- •Adults unable to consent on their own will not be eligible
- •Individuals unable to answer questionnaires in English will not be eligible.
- •Pregnant women will not be permitted to enroll as the use of this device in pregnancy is not well studied
- •Prisoners will not be included in this study.
结局指标
主要结局
Patient reported rate of alopecia rate of alopecia
时间窗: During active chemotherapy and completion of study, an average of 6 months
Patient-reported rate of alopecia as measured by the modified Dean Scale and VAS. Hair preservation is defined in this scale as \<50% hair loss (\< grade 2) or score of \<50 on VAS
次要结局
- Psychosocial assessments of chemotherapy-induced alopecia(During active chemotherapy and completion of study, an average of 6 months)
- Quality of life assessments of chemotherapy-induced alopecia(During active chemotherapy and completion of study, an average of 6 months)
研究者
Asma Dilawari
Assistant Professor of Medicine
Medstar Health Research Institute