Amma™ Portable Scalp Cooling System (PSCS) Study: A Post-market Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Early-stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage of participants with Grade 2 or lower hair loss
研究概览
简要总结
The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last chemotherapy (CT) treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) by comparing post-treatment photographs to pre-treatment photographs.
SECONDARY OBJECTIVES:
I. To assess safety of the Amma PSCS based on the occurrence of device-related adverse events, occurrence of scalp changes determined by physical examination, and patient symptoms with use of the PSCS.
II. To evaluate hair loss as measured by the patient at 3 weeks (±1 week) after the completion of the last treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE v5.0 or above) by comparing post-treatment photographs to baseline photographs.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically or cytologically confirmed breast cancer, stage I, II, or III.
- •A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent.
- •Plan to complete the current CT regimen within six months.
- •Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin. Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the Amma PSCS will not be used during the post-CT targeted and/or hormonal therapy period.
- •At least two years out from the last CT causing hair loss with complete recovery of hair.
- •Age >=21 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of <=
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale.
- •Autoimmune disease affecting hair, e.g., alopecia areata, systemic lupus with associated hair loss, others.
- •A history of whole brain radiation.
- •Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (doxorubicin and cyclophosphamide followed by paclitaxel (AC/T), epirubicin, cyclophosphamide, and docetaxel or paclitaxel (EC/T), docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin), and cyclophosphamide (TAC), etc.)
- •Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted.
- •Concurrent use of hair growth products, such as Nutrafol, minoxidil, and Keranique.
- •A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up.
- •History of persistent alopecia (any grade) induced by prior chemotherapeutic regimens.
- •History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss.
- •Cold sensitivity.
- •Intercurrent life-threatening malignancy.
- •Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism.
- •History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia.
- •Concurrent hematologic malignancy.
- •Concurrent treatment with any investigational agent.
- •Any reason the investigator does not believe the patient is a good candidate for the study.
- •Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitant administration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.
研究组 & 干预措施
Portable Scalp Cooling System (PSCS)
Participants will participate in training in AMMA use and will be asked to bring the device for use during each non-investigational, chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy, and for at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and 3 weeks after the last chemotherapy treatment. Questionnaires will be given throughout the study and 3 weeks after the last after the last chemotherapy treatment.
干预措施: Amma Portable Scalp Cooling System (PSCS) (Device)
Portable Scalp Cooling System (PSCS)
Participants will participate in training in AMMA use and will be asked to bring the device for use during each non-investigational, chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy, and for at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and 3 weeks after the last chemotherapy treatment. Questionnaires will be given throughout the study and 3 weeks after the last after the last chemotherapy treatment.
干预措施: Questionnaires (Other)
结局指标
主要结局
Percentage of participants with Grade 2 or lower hair loss
时间窗: Up to 7 months
The percentage of participants with Grade 1 hair loss (defined by the NCI CTCAE as \<50% of normal for that individual that is not obvious from a distance but only on close inspection) with supported photographs of the scalp taken at baseline and 3 weeks after completion of last non-investigational CT treatment/ infusion for comparison and evaluation will be reported with a 95% confidence interval.
次要结局
- Proportion of participants with device-related Adverse Events(Up to 7 months)
- Change in scores on the EORTC- QLQ-BR23(Up to 7 months)
- Change in total score on the Body Image Scale (BIS)(Up to 7 months)
- Proportion of participants assessment of hair loss as <50%(At 3 weeks after completion of last CT treatment/ infusion)