Evaluation Of Benefits of The Portable Scalp Cooling System (PSCS) in Metastatic Breast Cancer Patients on Taxane-Based Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Success in hair preservation
研究概览
简要总结
This clinical trial evaluates the benefits of a portable scalp cooling system (PSCS) for improving chemotherapy-induced hair loss in patients with breast cancer that has spread to other places in the body (metastatic) and are undergoing taxane-based chemotherapy. The PSCS is a new system designed to reduce chemotherapy induced hair loss. The PSCS is designed as a portable unit, allowing patients to leave the infusion center after chemotherapy is completed and finish scalp cooling at home. PSCS may help improve chemotherapy-induced hair loss in patients with metastatic breast cancer receiving chemotherapy.
详细描述
PRIMARY OBJECTIVE:
I. Measure efficacy of scalp cooling for patients undergoing taxane based chemotherapy for metastatic breast cancer.
SECONDARY OBJECTIVES:
I. Assess safety of PSCS in treating patients with metastatic breast cancer. II. Assess burden on nurses and infusion center team of patients using the PSCS.
III. Assess tolerability of PSCS. IV. Assess hair loss and recovery as assessed by the patient. V. Assess patient quality of life and satisfaction with treatment.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented informed consent of the participant
- •Age: >= 18 years
- •Eastern Cooperative Oncology Group (ECOG) =< 2
- •Ability to read and understand English or Spanish for questionnaires
- •Documented diagnosis of metastatic breast cancer with at least a 6 month life expectancy
- •A planned course of taxane based chemotherapy in the metastatic setting, including paclitaxel, docetaxel or abraxane
- •At least 6 months from the last chemotherapy causing hair loss with complete recovery of hair
- •Willing to be contacted for brief annual assessments for five years
- •Women of childbearing potential (WOCBP): negative urine pregnancy test
- •Agreement by females of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study
- •Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
排除标准
- •Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
- •A history of whole brain radiation with persistent hair thinning or alopecia, or concurrent whole brain radiation therapy
- •Exposure to other investigational agents, drugs, device or procedure that may cause hair loss
- •Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
- •Any cutaneous scalp metastases
- •Clinically significant liver dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
- •Clinically significant renal dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
- •A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
- •Evidence of untreated or poorly controlled hyper or hypothyroidism
- •American Society of Anesthesiologist Class >= 3
- •Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- •Pregnant or breastfeeding
- •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
结局指标
主要结局
Success in hair preservation
时间窗: At 4 weeks after completion of the 6th chemotherapy cycle
Hair loss will be measured by the patient according to the Dean Score. (Grade 0: no hair loss, grade 1: \> 0 - 25%; grade 2: \> 25 - 50%; grade 3: \> 50 - 75%; grade 4: \> 75%). Hair preservation was defined as hair loss no more than grade 2.
次要结局
- Tolerability of PSCS(Up to 1 year)
- Burden on nurses and infusion center team(Up to 1 year)
- Patients quality of life(Up to 30 days after the last dose of treatment)
- Hair loss recovery(Up to 1 year)
- Incidence of adverse events of PSCS(At 4 weeks, 3 months, and 6 months following the conclusion of 6 cycles of chemotherapy)